FDA Product Code
FDA Product Code HTY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3040
510(k) Clearances — 205 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K060654 | DSI PINS AND WIRES | Delta Surgical Instruments, Inc. | 2006-04-28 | Traditional | PDF ↗ |
| K060283 | TRANSET SYSTEM | Bonutti Research, Inc. | 2006-02-22 | Special | PDF ↗ |
| K052736 | ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT | Arthrex, Inc. | 2005-11-03 | Traditional | PDF ↗ |
| K051605 | SBI K-WIRES | Small Bone Innovations, LLC | 2005-08-10 | Traditional | PDF ↗ |
| K050259 | ARTHREX BIO-PIN | Arthrex, Inc. | 2005-05-27 | Traditional | PDF ↗ |
| K043339 | REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG | Xtremi-T, LLC | 2005-04-18 | Traditional | PDF ↗ |
| K050275 | MODIFICATION TO: INION OTPS BIODEGRADABLE PIN | Inion , Ltd. | 2005-03-07 | Special | PDF ↗ |
| K043106 | PINN-ACL CROSSPIN | Linvatec Corp. | 2005-01-19 | Traditional | PDF ↗ |
| K041355 | HUMERAL STAPLE | Smith & Nephew, Inc. | 2004-07-30 | Traditional | PDF ↗ |
| K041157 | MODIFICATION TO SMALL BONE FIXATION SYSTEM | Hand Innovations, Inc. | 2004-07-30 | Traditional | PDF ↗ |
| K041288 | MODIFICATION TO SMARTPIN | Linvatec Biomaterials, Inc. | 2004-06-10 | Special | PDF ↗ |
| K040500 | ARTHROTEK LACTONAIL | Arthrotek, Inc. | 2004-05-25 | Traditional | PDF ↗ |
| K033717 | TRANSET FRACTURE FIXATION SYSTEM | Bonutti Research, Inc. | 2004-02-25 | Traditional | PDF ↗ |
| K033968 | HANSSON PIN SYSTEM | Howmedica Osteonics Corp. | 2004-02-20 | Traditional | PDF ↗ |
| K033406 | SMALL BONE FIXATION SYSTEM | Hand Innovations, Inc. | 2004-01-15 | Special | PDF ↗ |
| K024185 | BIODHOC | Future Medical Systems, SA | 2004-01-15 | Traditional | PDF ↗ |
| K032687 | ACE NANCY NAIL | DePuy Orthopaedics, Inc. | 2003-10-06 | Traditional | PDF ↗ |
| K031712 | INION OTPS BIODEGRADABLE PIN | Inion , Ltd. | 2003-08-28 | Traditional | PDF ↗ |
| K031083 | OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500 | Opus Medical, Inc. | 2003-06-12 | Traditional | PDF ↗ |
| K030665 | BONE WIRE | Stork Instrumente GmbH | 2003-03-25 | Traditional | PDF ↗ |
| K022597 | K-FIX | New Deal, S.A. | 2002-11-01 | Traditional | PDF ↗ |
| K022599 | NEWDEAL K WIRE | New Deal, S.A. | 2002-10-30 | Traditional | PDF ↗ |
| K022531 | 2MM PEDIATRIC FLEX NAIL | Biomet, Inc. | 2002-08-26 | Special | PDF ↗ |
| K013888 | FIXATION (STEINMANN) PINS | Miltex, Inc. | 2002-05-01 | Traditional | PDF ↗ |
| K014305 | RESORBABLE LACTOSORB-L ACL CROSSPIN | Arthrotek, Inc. | 2002-03-29 | Traditional | PDF ↗ |
| K013781 | RIDIDFIX 2.7MM BTB CROSS PIN KIT | Mitek Products | 2002-02-06 | Traditional | PDF ↗ |
| K013424 | INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND | Hand Innovations, Inc. | 2001-12-20 | Traditional | PDF ↗ |
| K012125 | OPUS MAGNUM ANCHOR & INSERTER | Opus Medical, Inc. | 2001-09-17 | Traditional | PDF ↗ |
| K012161 | FLEX-NAILS | Fixano SA | 2001-08-24 | Traditional | PDF ↗ |
| K011522 | RESORBABLE BONE PINS | Biomet, Inc. | 2001-07-31 | Traditional | PDF ↗ |
| K010983 | PLLA PIN | Bionx Implants, Inc. | 2001-06-13 | Special | PDF ↗ |
| K010479 | MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR | Bonutti Research, Inc. | 2001-05-08 | Traditional | PDF ↗ |
| K003527 | MODIFICATION TO SYNTHES (USA) POLYPIN | Synthes (Usa) | 2001-04-09 | Traditional | PDF ↗ |
| K003659 | PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 | Bionx Implants, Inc. | 2001-02-20 | Traditional | PDF ↗ |
| K002125 | PINS AND WIRES | Implant Resource, Inc. | 2000-10-11 | Traditional | PDF ↗ |
| K991971 | ARTHREX CHONDRAL DART, MODEL AR-4005B-18 | Arthrex, Inc. | 2000-08-04 | Traditional | PDF ↗ |
| K994232 | PHALANGEAL FIXATION SYSTEM | Medcanica, Inc. | 2000-03-01 | Traditional | PDF ↗ |
| K991064 | METACARPAL FIXATION SYSTEM | Medcanica, Inc. | 1999-06-23 | Traditional | PDF ↗ |
| K990291 | LACTOSORB BONE PIN | Biomet, Inc. | 1999-03-23 | Traditional | PDF ↗ |
| K983121 | NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220 | Syntec Scientific Corp. | 1998-10-05 | Traditional | PDF ↗ |
| K982719 | THE BONE TIE | Surgicraft , Ltd. | 1998-09-25 | Traditional | PDF ↗ |
| K980854 | RETROGRADE PEDIATRIC NAIL | Encore Orthopedics, Inc. | 1998-08-11 | Traditional | PDF ↗ |
| K974341 | MITEK BTB ABSORBABLE (PLA) CROSS PIN | Mitek Products | 1998-04-16 | Traditional | PDF ↗ |
| K974291 | MITEK BTB ABSORBABLE (PLA) CROSS PIN | Mitek Products | 1998-03-05 | Traditional | PDF ↗ |
| K973240 | SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION | Synthes (Usa) | 1997-11-20 | Traditional | PDF ↗ |
| K971962 | OSTEO KIRSCHNER WIRES | Osteonics Corp. | 1997-08-11 | Traditional | PDF ↗ |
| K971783 | SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM | Synthes (Usa) | 1997-07-18 | Traditional | PDF ↗ |
| K971453 | ORTHOTEC K-CAP SYSTEM | Orthotech | 1997-06-24 | Traditional | PDF ↗ |
| K961608 | SYNTHES (U.S.A.) POLYPIN | Synthes (Usa) | 1997-05-09 | Traditional | PDF ↗ |
| K970733 | SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM | Synthes (Usa) | 1997-04-02 | Traditional | PDF ↗ |
| K970036 | FIXATION PIN OR ROD | United States Surgical, A Division of Tyco Healthc | 1997-03-25 | Traditional | PDF ↗ |
| K970013 | BIORIGID NAIL TIBIA | Aap GmbH and Co. Betriebs KG | 1997-03-13 | Traditional | PDF ↗ |
| K964500 | ACUMED TENSION BAND PIN | Acu Med, Inc. | 1996-12-09 | Traditional | PDF ↗ |
| K964087 | BLOCK STOP WIRES | Ferguson Medical | 1996-11-25 | Traditional | PDF ↗ |
| K963367 | RMS K-WIRE | Rms Div. | 1996-10-30 | Traditional | PDF ↗ |
| K961522 | KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN | Synvasive Technology, Inc. | 1996-09-23 | Traditional | PDF ↗ |
| K960642 | NANCY NAIL | Landos, Inc. | 1996-05-17 | Traditional | PDF ↗ |
| K960482 | K-WIRE | American Medical Specialties, Inc. | 1996-04-09 | Traditional | PDF ↗ |
| K960483 | STEINMAN PIN | American Medical Specialties, Inc. | 1996-04-09 | Traditional | PDF ↗ |
| K960385 | STERILE KIRSCHNER WIRES AND STEINMANN PINS | Depuy, Inc. | 1996-03-27 | Traditional | PDF ↗ |
| K955806 | HOWMEDICA BIOABSORBABLE PIN | Howmedica, Inc. | 1996-02-15 | Traditional | PDF ↗ |
| K954543 | GO UNIVERSALK-WIRE FLUTED DRILL | Genesis Orthopedics, Inc. | 1995-12-08 | Traditional | PDF ↗ |
| K953194 | LACTOSORB BONE PIN | Biomet, Inc. | 1995-10-31 | Traditional | PDF ↗ |
| K954001 | SPETZLER PIN | Howmedica Corp. | 1995-10-26 | Traditional | PDF ↗ |
| K943856 | FIXATION PINS/WIRES | Acu Med, Inc. | 1995-07-06 | Traditional | PDF ↗ |
| K945639 | SPETZLER PIN | Howmedica Corp. | 1995-04-14 | Traditional | PDF ↗ |
| K940669 | J.B.S. B.A.C. PIN | J.B.S., S.A. | 1994-11-14 | Traditional | PDF ↗ |
| K940666 | JBS SMOOTH FIXATION PIN | J.B.S., S.A. | 1994-11-14 | Traditional | PDF ↗ |
| K940673 | J.B.S. SELF-TAPPING THREADED PIN | J.B.S., S.A. | 1994-11-14 | Traditional | PDF ↗ |
| K941434 | K-WIRES AND STEINMANN PINS | Omega Surgical Instruments, Inc. | 1994-10-03 | Traditional | PDF ↗ |
| K925098 | BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE | Bioscience, Inc. | 1994-07-19 | Traditional | PDF ↗ |
| K931836 | ACUFEX SMOOTH AND THREADED PINS | Acufex Microsurgical, Inc. | 1994-06-28 | Traditional | PDF ↗ |
| K931697 | FIXATION PIN | Orthologic Corp. | 1994-05-12 | Traditional | PDF ↗ |
| K930969 | BAUMER PINS | Baumer Ortopedia , Ltd. | 1994-03-29 | Traditional | PDF ↗ |
| K932348 | ORTHOPEDIC SMOOTH PIN FIXATION | Osteomed Corp. | 1994-03-01 | Traditional | PDF ↗ |
| K940109 | TAVA K-WIRE | Tava Surgical Instruments | 1994-02-22 | Traditional | PDF ↗ |
| K922766 | ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION | Acufex Microsurgical, Inc. | 1993-07-09 | Traditional | PDF ↗ |
| K925301 | OTI ORTHOPEDIC FASTENER SYSTEM | Osteo Technology, Inc. | 1993-03-16 | Traditional | PDF ↗ |
| K922194 | OSTEO STEINMANN PIN | Osteo AG | 1992-07-23 | Traditional | PDF ↗ |
| K922193 | OSTEO KIRSCHNER WIRE | Osteo AG | 1992-07-23 | Traditional | PDF ↗ |
| K911375 | G-PIN | Dr.M.A.Galluzzo | 1991-09-23 | Traditional | PDF ↗ |
| K911452 | FIXATION PIN | Simpex, Inc. | 1991-04-12 | Traditional | PDF ↗ |
| K911505 | FIXATION WIRE | Simpex, Inc. | 1991-04-12 | Traditional | PDF ↗ |
| K905345 | K-WIRE | O'Tec Corp. | 1990-12-11 | Traditional | PDF ↗ |
| K905337 | STEINMAN PIN | O'Tec Corp. | 1990-12-11 | Traditional | PDF ↗ |
| K905341 | RUSH PIN | O'Tec Corp. | 1990-12-11 | Traditional | PDF ↗ |
| K903265 | STEINMAN PIN | Onyx Medical Corp. | 1990-07-30 | Traditional | PDF ↗ |
| K903264 | K-WIRE | Onyx Medical Corp. | 1990-07-30 | Traditional | PDF ↗ |
| K901273 | L.M.S. SELF-DETACHABLE BROACH WITH STOP | Med-Tek Corp. | 1990-06-05 | Traditional | PDF ↗ |
| K890902 | BIOFIX* BIODEGRADABLE FIXATION ROD | Davis & Geck, Inc. | 1989-11-03 | Traditional | PDF ↗ |
| K895079 | ACE BEADED K-WIRES ACE OLIVE WIRES | Buckman Co., Inc. | 1989-09-13 | Traditional | PDF ↗ |
| K874913 | ORTHOMET PIN SYSTEM | Orthomet, Inc. | 1988-01-07 | Traditional | PDF ↗ |
| K872842 | PIN, HIP, KNOWLES | Military Engineering, Inc. | 1987-08-07 | Traditional | PDF ↗ |
| K864912 | PDS (POLYDIOXANON) ABSORBABLE PIN | Johnson & Johnson Professionals, Inc. | 1987-07-09 | Traditional | PDF ↗ |
| K863734 | STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS | Micro-Aire Surgical Instruments, Inc. | 1986-10-20 | Traditional | PDF ↗ |
| K863119 | CANNULATED LAG SCREWS | Downs Surgical , Ltd. | 1986-09-03 | Traditional | PDF ↗ |
| K860590 | ACE UNILATERAL FIXATOR | Buckman Co., Inc. | 1986-03-07 | Traditional | PDF ↗ |
| K852560 | PINSET, BONE, RUSH 9-1/2 THRU 20-3/4 INCHES LONG | The Huxley Instrument Corp. | 1985-06-28 | Traditional | PDF ↗ |
| K852561 | PIN SET, BONEM, RUSH, 1 THRU 10 INCHES LONG | The Huxley Instrument Corp. | 1985-06-28 | Traditional | PDF ↗ |
| K852562 | PIN SET, BONE, RUSH, 4 THRU 10 1/2 INCHES LONG | The Huxley Instrument Corp. | 1985-06-28 | Traditional | PDF ↗ |
Product code HTY · Class II · Orthopedic. Data: openFDA.