FDA Product Code
FDA Product Code HWC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3040
510(k) Clearances — 1,069 records · page 7 of 11
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K043176 | ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM | Arc Surgical, LLC | 2005-06-17 | Traditional | PDF ↗ |
| K050767 | STERLING INTERFERENCE SCREW ST | Regeneration Technologies, Inc. | 2005-06-09 | Traditional | PDF ↗ |
| K050924 | MERETE DUOTHREADTM BONE SCREW | Merete Medical GmbH | 2005-05-27 | Traditional | PDF ↗ |
| K050754 | PRECIMED CANNULATED SCREW SYSTEM | Precimed, Inc. | 2005-05-18 | Traditional | PDF ↗ |
| K050749 | ARTHREX TAK FAMILY | Arthrex, Inc. | 2005-05-12 | Traditional | PDF ↗ |
| K050683 | SYNTHES (USA) 3.5MM CONICAL SCREWS | Synthes (Usa) | 2005-04-27 | Traditional | PDF ↗ |
| K050636 | SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS | Synthes (Usa) | 2005-04-21 | Traditional | PDF ↗ |
| K050358 | ARTHERX CORKSCREW FT II SUTURE ANCHOR | Arthrex, Inc. | 2005-04-15 | Special | PDF ↗ |
| K050819 | CHARLOTTE SNAP-OFF SCREW | Wrightmedicaltechnologyinc | 2005-04-11 | Special | PDF ↗ |
| K050497 | BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET | Linvatec Corp. | 2005-03-25 | Special | PDF ↗ |
| K050634 | MODIFICATION TO: ARTHREX V-TAK | Arthrex, Inc. | 2005-03-21 | Special | PDF ↗ |
| K050346 | STABILIZATION SCREW | New Deal, S.A. | 2005-03-17 | Traditional | PDF ↗ |
| K043410 | EPIPHYSIS SCREW | I.T.S. Implantat-Technologie-Systeme GmbH | 2005-02-24 | Traditional | PDF ↗ |
| K043142 | INION OTPS BIODEGRADABLE MINI PLATING SYSTEM | Inion , Ltd. | 2005-02-18 | Traditional | PDF ↗ |
| K050226 | ASIAN INTRAMEDULLARY HIP SCREW NAILS | Smith & Nephew, Inc. | 2005-02-11 | Special | PDF ↗ |
| K043185 | SYNTHES 3.5MM CORTEX SCREWS | Synthes (Usa) | 2005-02-03 | Traditional | PDF ↗ |
| K043583 | CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003 | Wrightmedicaltechnologyinc | 2005-01-26 | Special | PDF ↗ |
| K043102 | MULTI-USE COMPRESSION SCREW | Wrightmedicaltechnologyinc | 2005-01-21 | Traditional | PDF ↗ |
| K043281 | CHARLOTTE HIGH-DEMAND COMPRESSION SCREW | Wrightmedicaltechnologyinc | 2005-01-19 | Traditional | PDF ↗ |
| K042079 | OSS/(SCARF)- AND OSW-SCREW | O.M.T. Oberflachen-Und Materialtechnologie GmbH | 2004-12-20 | Traditional | PDF ↗ |
| K032830 | PLLA CANNULATED INTERFERENCE SCREW | Advanced Biomaterials | 2004-12-14 | Traditional | PDF ↗ |
| K042552 | BIO-CORE INTERFERENCE SCREW | Biomet, Inc. | 2004-12-14 | Traditional | PDF ↗ |
| K042584 | OPUS MINIMAGNUM ANCHOR WITH INSERTER | Opus Medical, Inc. | 2004-12-14 | Traditional | PDF ↗ |
| K043337 | ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR | Arthrex, Inc. | 2004-12-14 | Special | PDF ↗ |
| K041075 | FASTIN RC ANCHOR | Depuy Mitek, A Johnson & Johnson Company | 2004-11-09 | Traditional | PDF ↗ |
| K041069 | SPIRALOK ANCHOR | Depuy Mitek, A Johnson & Johnson Company | 2004-11-09 | Traditional | PDF ↗ |
| K042796 | ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE | Coapt Systems, Inc. | 2004-11-05 | Special | PDF ↗ |
| K041356 | ARTHREX TENODESIS SCREW FAMILY | Arthrex, Inc. | 2004-11-04 | Traditional | PDF ↗ |
| K042778 | BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE | Linvatec Corp. | 2004-11-04 | Special | PDF ↗ |
| K041189 | ARTHREX TRIMIT FAMILY | Arthrex, Inc. | 2004-11-04 | Traditional | PDF ↗ |
| K041961 | SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM | Scandius Biomedical, Inc. | 2004-10-20 | Traditional | PDF ↗ |
| K042356 | SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS | Synthes (Usa) | 2004-10-07 | Traditional | PDF ↗ |
| K041835 | ENDOTINE MIDFACE B 4.5 DEVICE | Coapt Systems, Inc. | 2004-09-28 | Traditional | PDF ↗ |
| K042030 | HYPROCURE SUBTALAR IMPLANT SYSTEM | Graham Medical Technologies, LLC | 2004-09-16 | Traditional | PDF ↗ |
| K042310 | ORTHO-PRO CANNULATED BONE SCREWS | Ortho-Pro, LLC | 2004-09-16 | Traditional | PDF ↗ |
| K042244 | BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE | Triage Medical, Inc. | 2004-09-16 | Special | PDF ↗ |
| K042295 | SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020 | Linvatec Biomaterials, Ltd. | 2004-09-16 | Special | PDF ↗ |
| K041936 | BIOPRO SUBTALAR IMPLANT | Biopro, Inc. | 2004-09-08 | Traditional | PDF ↗ |
| K041749 | SCANDIUS ACL RECONSTRUCTION SYSTEM | Scandius Biomedical, Inc. | 2004-09-08 | Traditional | PDF ↗ |
| K041533 | SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS | Synthes (Usa) | 2004-09-01 | Traditional | PDF ↗ |
| K042078 | ENDOTINE FOREHEAD TRIPLE DEVICE | Coapt Systems, Inc. | 2004-08-27 | Special | PDF ↗ |
| K041456 | SNAP-OFF SCREWS | Fournitures Hospitalieres Industrie | 2004-08-25 | Traditional | PDF ↗ |
| K040542 | SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW | Smith & Nephew, Inc. | 2004-08-19 | Traditional | PDF ↗ |
| K031714 | INION TRINION BIODEGRADABLE MENISCUS SCREW | Inion , Ltd. | 2004-08-16 | Traditional | PDF ↗ |
| K041289 | TALUS OF VILEX (TOV) | Vilex, Inc. | 2004-08-05 | Traditional | PDF ↗ |
| K041287 | VILEX BONE PLATE SYSTEM | Vilex, Inc. | 2004-08-05 | Traditional | PDF ↗ |
| K041274 | RESORBABLE INTERFERENCE SCREW | Arthrotek, Inc. | 2004-07-28 | Traditional | PDF ↗ |
| K033355 | LACTOSCREW SCREW ANCHOR | Biomet Orthopedics, Inc. | 2004-06-30 | Traditional | PDF ↗ |
| K031939 | BIO-EUROLIG INTERFERENCE SCREW | Fournitures Hospitalieres Industrie | 2004-06-24 | Traditional | PDF ↗ |
| K040701 | SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS | Synthes (Usa) | 2004-06-15 | Traditional | PDF ↗ |
| K040265 | LITTLE GRAFTER SCREW | Biocomposites, Ltd. | 2004-05-28 | Traditional | PDF ↗ |
| K040656 | MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW | Smith & Nephew, Inc. | 2004-05-25 | Traditional | PDF ↗ |
| K040475 | MICROMAX SUTURE ANCHOR | Biomet, Inc. | 2004-05-21 | Traditional | PDF ↗ |
| K040740 | ENDOTINE TRANSBLEPH DEVICE | Coapt Systems, Inc. | 2004-05-10 | Traditional | PDF ↗ |
| K032894 | OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, | Linvatec Biomaterials, Inc. | 2004-05-07 | Traditional | PDF ↗ |
| K032447 | CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED | Linvatec Biomaterials, Ltd. | 2004-04-16 | Special | PDF ↗ |
| K040331 | SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS | Smith & Nephew, Inc. | 2004-04-14 | Traditional | PDF ↗ |
| K032717 | BIOCRYL RAPIDE INTERFERENCE SCREW | Mitek Worldwide | 2004-03-31 | Traditional | PDF ↗ |
| K040594 | HERCULON SOFT TISSUE REATTACHMENT SYSTEM | United States Surgical, A Division of Tyco Healthc | 2004-03-31 | Special | PDF ↗ |
| K033975 | SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS | Synthes (Usa) | 2004-03-01 | Traditional | PDF ↗ |
| K040356 | KOMPRESSOR SCREW SYSTEM | Kinetikos Medical, Inc. | 2004-03-01 | Special | PDF ↗ |
| K033792 | BILOK ST SCREW | Biocomposites, Ltd. | 2004-03-01 | Traditional | PDF ↗ |
| K033749 | TITANIUM CANNULATED INTERFERENCE SCREW | Advanced Biomaterials | 2004-02-23 | Traditional | PDF ↗ |
| K033639 | ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM | Acumed, LLC | 2004-01-15 | Traditional | PDF ↗ |
| K032966 | THE ANSWER SCREW SUPPLEMENTATION SYSTEM | Simplicity Orthopedic Solutions, LLC | 2004-01-13 | Traditional | PDF ↗ |
| K033804 | BIOANCHOR WITH DISPOSABLE DRIVER | Linvatec Corp. | 2003-12-31 | Special | PDF ↗ |
| K033524 | COAPT ENDOTINE CHIN 3.5 DEVICE | Coapt Systems, Inc. | 2003-12-18 | Traditional | PDF ↗ |
| K032902 | SUBTALAR ARTHRORISIS IMPLANT | Nexa Orthopedics, Inc. | 2003-12-15 | Traditional | PDF ↗ |
| K033740 | LORENZ STERNAL CLOSURE SYSTEM | Walter Lorenz Surgical, Inc. | 2003-12-15 | Special | PDF ↗ |
| K033252 | MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM | Stryker Endoscopy | 2003-11-13 | Special | PDF ↗ |
| K033233 | LACTOSORB TIBIAL L-15 SCREW AND WASHER | Biomet, Inc. | 2003-11-05 | Special | PDF ↗ |
| K032682 | STS SCREW | Ortho-Pro, LLC | 2003-10-22 | Traditional | PDF ↗ |
| K032167 | BIO-INTRAFIX TIBIAL SCREW AND SHEATH | Mitek Worldwide | 2003-10-15 | Traditional | PDF ↗ |
| K032770 | ENDOTINE FOREHEAD DEVICE | Coapt Systems, Inc. | 2003-10-08 | Special | PDF ↗ |
| K032098 | ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B | Arthrex, Inc. | 2003-10-07 | Traditional | PDF ↗ |
| K032072 | LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE | Arthrotek, Inc. | 2003-10-01 | Traditional | PDF ↗ |
| K031945 | ARTHREX TRIMIT SCREW, MODEL AR-4161B | Arthrex, Inc. | 2003-09-22 | Traditional | PDF ↗ |
| K031937 | ALANTECH GRAFT FIXATION SCREW | Arthrocare Corp. | 2003-09-04 | Traditional | PDF ↗ |
| K031155 | OSTEOMED SUBTALAR IMPLANT SYSTEM | Osteomed LP | 2003-08-22 | Traditional | PDF ↗ |
| K032228 | LORENZ 2.4 SELF DRILLING SCREWS | Walter Lorenz Surgical, Inc. | 2003-08-11 | Special | PDF ↗ |
| K032224 | BIORCI SCREW | Smith & Nephew, Inc. | 2003-08-08 | Special | PDF ↗ |
| K030302 | HBS HEADLESS BONE SCREW | Schoening & Assoc., Inc. | 2003-08-08 | Traditional | PDF ↗ |
| K031050 | PCW PERCUTANEOUS COMPRESSION WIRE | Millennium Medical Technologies, Inc. | 2003-07-14 | Traditional | PDF ↗ |
| K031685 | TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318 | Smith & Nephew, Inc. | 2003-07-01 | Special | PDF ↗ |
| K030995 | MINILOK QUICKANCHOR PLUS | Mitek Worldwide | 2003-06-26 | Traditional | PDF ↗ |
| K031751 | RAPIDFIRE SELF DRILLING SCREWS | Walter Lorenz Surgical, Inc. | 2003-06-26 | Special | PDF ↗ |
| K030900 | INION OTPS BIODEGRADABLE FIXATON SYSTEM | Inion , Ltd. | 2003-06-19 | Traditional | PDF ↗ |
| K030848 | PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX | Karl Storz Endoscopy | 2003-06-02 | Traditional | PDF ↗ |
| K023887 | INION OTPS BIODEGRADABLE MINI PLATING SYSTEM | Inion , Ltd. | 2003-05-30 | Traditional | PDF ↗ |
| K030388 | IMPACT SUTURE ANCHOR. MODEL 433510 | Bionx Implants, Ltd. | 2003-04-24 | Traditional | PDF ↗ |
| K023365 | LEFORTE SYSTEM BONE SCREW | Jeil Medical Corporation | 2003-04-18 | Traditional | PDF ↗ |
| K023192 | STRYKER BIOZIP SUTURE ANCHOR | Stryker Endoscopy | 2003-03-20 | Traditional | PDF ↗ |
| K030368 | KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW | KARL STORZ Endoscopy-America, Inc. | 2003-03-20 | Traditional | PDF ↗ |
| K030706 | EBI DYNAFIX COMPRESSION BONE SCREW | Ebi, L.P. | 2003-03-20 | Traditional | PDF ↗ |
| K024115 | MICROFIX QUICKANCHOR PLUS | Mitek Worldwide | 2003-03-13 | Traditional | PDF ↗ |
| K023013 | STRYKER XCEL ANCHOR SYSTEM | Stryker Endoscopy | 2003-02-26 | Traditional | PDF ↗ |
| K024233 | KOMPRESSOR SCREW SYSTEM | Kinetikos Medical, Inc. | 2003-02-06 | Traditional | PDF ↗ |
| K024086 | PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM | Biomet Orthopedics, Inc. | 2003-01-09 | Special | PDF ↗ |
| K023922 | COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197 | Coapt Systems, Inc. | 2002-12-20 | Special | PDF ↗ |
| K024060 | MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM | Howmedica Osteonics Corp. | 2002-12-20 | Special | PDF ↗ |
Product code HWC · Class II · Orthopedic. Data: openFDA.