FDA Product Code
FDA Product Code JEC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3040
510(k) Clearances — 85 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K203605 | SteriTrak | Arbutus Medical, Inc. | 2021-04-23 | Traditional | PDF ↗ |
| K193256 | Anjon Bremer Halo System | Anjon Holdings, LLC | 2020-03-02 | Traditional | PDF ↗ |
| K192465 | DigiFix Sterile Kit | Virak Orthopedics, LLC | 2019-10-10 | Special | PDF ↗ |
| K181192 | PIP Fix | Hand Biomechanics Lab, Inc. | 2018-10-22 | Traditional | PDF ↗ |
| K171863 | Anjon Bremer Halo System | Anjon Holdings, LLC | 2018-03-19 | Traditional | PDF ↗ |
| K163028 | Medline ReNewal Reprocessed Stryker External Fixation Devices | Surgical Instrument Service and Savings, Inc. | 2016-12-28 | Traditional | PDF ↗ |
| K132731 | DIGIFIX EXTERNAL FIXATION SYSTEM | Virak Orthopedic Research, LLC | 2014-01-10 | Traditional | PDF ↗ |
| K102885 | HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX | Stryker Corp. | 2011-01-14 | Special | PDF ↗ |
| K082679 | LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X | Sintea Biotech, Inc. | 2009-04-07 | Special | PDF ↗ |
| K072432 | F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE | Hand Biomechanics Lab, Inc. | 2008-01-09 | Traditional | PDF ↗ |
| K071476 | SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP | Synthes (Usa) | 2007-08-24 | Traditional | PDF ↗ |
| K042066 | KLSA MARTIN HAND DISTRACTOR | KLS-Martin L.P. | 2004-08-25 | Traditional | PDF ↗ |
| K032427 | FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM | Meridan Medical | 2003-10-09 | Traditional | PDF ↗ |
| K031941 | HOFFMANN II COMPACT BALTIMORE COUPLING | Howmedica Osteonics Corp. | 2003-07-24 | Special | PDF ↗ |
| K030519 | WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS | Hand Biomechanics Lab, Inc. | 2003-06-10 | Traditional | PDF ↗ |
| K022676 | ORTHOGUARD AB ANTIMICROBIAL SLEEVE | Smith & Nephew, Inc. | 2002-09-23 | Special | PDF ↗ |
| K022065 | SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X | Sintea Biotech, Inc. | 2002-08-06 | Traditional | PDF ↗ |
| K012193 | AMC ANTIMICROBIAL PIN/WIRE SLEEVE | Smith & Nephew, Inc. | 2002-07-11 | Traditional | PDF ↗ |
| K013818 | AUTOGENESIS AUTOMATOR, MODEL M1000 | Autogenesis, Inc. | 2001-12-05 | Special | PDF ↗ |
| K003848 | HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST | Howmedica Osteonics Corp. | 2001-01-11 | Special | PDF ↗ |
| K993099 | BREMER HALO SYSTEM TITANIUM SKULL PIN | Depuyacromed | 1999-12-15 | Traditional | PDF ↗ |
| K991732 | CENTRAFIX EXTERNAL FIXATOR | Owandar Medical, Ltd. | 1999-05-21 | Traditional | PDF ↗ |
| K984442 | AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 | Hand Biomechanics Lab, Inc. | 1999-02-12 | Traditional | PDF ↗ |
| K981423 | AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000 | Autogenesis, Inc. | 1998-05-20 | Special | PDF ↗ |
| K971755 | HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM | Howmedica Corp. | 1997-07-17 | Traditional | PDF ↗ |
| K965029 | STABLELOC II EXTERNAL FIXATOR | Acu Med, Inc. | 1997-02-19 | Traditional | PDF ↗ |
| K963614 | MONOTUBE CARBON TUBE | Howmedica Corp. | 1996-11-06 | Traditional | PDF ↗ |
| K961916 | HOFFMANN II CARBON CONNECTING ROD | Howmedica, Inc. | 1996-08-01 | Traditional | PDF ↗ |
| K961618 | MONOTUBE TUBE TO RING CLAMP | Howmedica Corp. | 1996-05-28 | Traditional | PDF ↗ |
| K960782 | TITANIUM TUBE TO TUBE CLAMP | Synthes (Usa) | 1996-05-08 | Traditional | PDF ↗ |
| K954838 | EZ FIX | Biodynamic Technologies, Inc. | 1996-01-24 | Traditional | PDF ↗ |
| K954667 | MONOTUBE TUBE-TO-TUBE CLAMP | Howmedica Corp. | 1996-01-11 | Traditional | PDF ↗ |
| K952330 | EXTERNAL FIXATOR | Acu Med, Inc. | 1995-10-05 | Traditional | PDF ↗ |
| K952730 | HOFFMANN II EXTERNAL FIXATION SYSTEM | Howmedica Corp. | 1995-09-08 | Traditional | PDF ↗ |
| K944092 | ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM | Orthofix Srl | 1995-04-04 | Traditional | PDF ↗ |
| K943857 | EXTERNAL FIXATOR | Acu Med, Inc. | 1995-01-27 | Traditional | PDF ↗ |
| K933968 | ACE PELVIC STABILIZER | Ace Medical Co. | 1994-06-16 | Traditional | PDF ↗ |
| K922796 | PELVIC C-CLAMP | Synthes (Usa) | 1994-03-10 | Traditional | PDF ↗ |
| K931578 | TEXAS SCOTTISH RITE EASY/LOCK FIXATOR | Applied Osteo Systems, Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K934698 | HOWMEDICA MONO-TUBE SINGLE PIN CLAMP | Howmedica Corp. | 1994-02-22 | Traditional | PDF ↗ |
| K936124 | HOWMEDICA MONOTUBE T-CONNECTOR | Howmedica, Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K936045 | ACE UNILATERAL FIXATOR II | Ace Orthopedic Manufacturing Co. | 1994-02-22 | Traditional | PDF ↗ |
| K930153 | SYSTEM III HALO RING | Jerome Medical | 1993-08-06 | Traditional | PDF ↗ |
| K920117 | HALO ESPRIT | Itm Corp. | 1992-10-06 | Traditional | PDF ↗ |
| K920149 | OSTEO EX-FI-RE | Osteo AG | 1992-04-09 | Traditional | PDF ↗ |
| K915800 | BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN | Bremer Medical, Inc. | 1992-03-16 | Traditional | PDF ↗ |
| K914858 | ACE OPEN-BACK HALO RING | Ace Medical Co. | 1991-11-21 | Traditional | PDF ↗ |
| K894959 | CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO | Alphatec Mfg., Inc. | 1990-09-14 | Traditional | PDF ↗ |
| K903105 | OLIVE K-WIRES | Danek Medical, Inc. | 1990-09-06 | Traditional | PDF ↗ |
| K901984 | ACE WIRE TENSION CLAMP | Buckman Co., Inc. | 1990-06-21 | Traditional | PDF ↗ |
| K894098 | SYNTHES EXTERNAL FIXATION BONE CLIP | Synthes (Usa) | 1990-04-30 | Traditional | PDF ↗ |
| K894982 | ACE WIRE TENSION CLAMP | Buckman Co., Inc. | 1990-01-11 | Traditional | PDF ↗ |
| K892638 | TRACER DYNAMIC AXIAL FIXATION | Tracer Medical | 1989-08-11 | Traditional | PDF ↗ |
| K884798 | AME PINSITE SHIELD(TM) | American Medical Electronics, Inc. | 1989-02-10 | Traditional | PDF ↗ |
| K884242 | MODIFIED CHICK AMBULATORY HALO | Chick Medical Products | 1988-12-29 | Traditional | PDF ↗ |
| K882877 | JMS CERVICAL TRACTION DEVICE/HALO DEVICE | Jerome Medical | 1988-09-30 | Traditional | PDF ↗ |
| K881896 | KIRSCHNER SUPER-FIXATION SYSTEM | Kirschner Medical Corp. | 1988-07-28 | Traditional | PDF ↗ |
| K881673 | LIMA-LTO ECS EXTERNAL CIRCULAR STABILIZER | Lima-Lto, Inc. | 1988-06-03 | Traditional | PDF ↗ |
| K880282 | LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER | Lima-Lto, Inc. | 1988-02-18 | Traditional | PDF ↗ |
| K872538 | VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS | Vitaphore Corp. | 1987-07-10 | Traditional | PDF ↗ |
| K852397 | EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129) | Howmedica Corp. | 1985-08-09 | Traditional | PDF ↗ |
| K842493 | AGEE EXTERNAL FIXATOR | The Hand Biomechanics Research Laboratory | 1985-02-13 | Traditional | PDF ↗ |
| K842343 | SABA-COOMBS MINI EXTERNAL FIXATOR | Zimmer, Inc. | 1984-09-11 | Traditional | PDF ↗ |
| K841334 | RICHARDS FIXATOR SYSTEM | Richards Medical Co., Inc. | 1984-05-16 | Traditional | PDF ↗ |
| K840856 | MODULAR CONSTRUCT FRAME EXTERNAL FIXA | Precision Medical Devices, Inc. | 1984-04-25 | Traditional | PDF ↗ |
| K833114 | OXFORD MARK 2 EXTERNAL FIXATOR | Johnson & Johnson Professionals, Inc. | 1983-10-20 | Traditional | PDF ↗ |
| K831576 | ORTHOFIX | Electro-Biology, Inc. | 1983-06-08 | Traditional | PDF ↗ |
| K830154 | COLLES FRACTURE FRAME | Richard'S Medical Equip., Inc. | 1983-02-02 | Traditional | PDF ↗ |
| K822780 | CERVICAL BRACE | Jerome Medical | 1982-10-06 | Traditional | PDF ↗ |
| K803166 | DOUBLE BALL JOINT | Howmedica Corp. | 1981-01-09 | Traditional | PDF ↗ |
| K802814 | ORTHOFIX AXIALEXTERNAL FIXATION SYS. | Cintor Orthopaedic Div. | 1980-12-10 | Traditional | PDF ↗ |
| K802723 | EXTENDED BALLJOINT GRIP | Howmedica Corp. | 1980-11-19 | Traditional | PDF ↗ |
| K802722 | EXTERNAL FIXATION SYSTEM | Howmedica Corp. | 1980-11-19 | Traditional | PDF ↗ |
| K802776 | HOFFMAN LEG LENGTHENING DEVICE | Howmedica Corp. | 1980-11-19 | Traditional | PDF ↗ |
| K800184 | OXFORD EXTERNAL FIXATION SYSTEM | Downs Surgical , Ltd. | 1980-02-11 | Traditional | PDF ↗ |
| K792561 | MINI-H-FIXATION | Geny Medical, Inc. | 1979-12-19 | Traditional | PDF ↗ |
| K791466 | ACE EXTERNAL BONE CLAMP PART #S11 | Ace Orthopedic Manufacturing Co. | 1979-08-16 | Traditional | PDF ↗ |
| K790262 | UNIVERSAL EXTERNAL FIXATION ASSEMBLY | Zimmer, Inc. | 1979-02-13 | Traditional | PDF ↗ |
| K781840 | EXTERNAL ARTICULATION | Ace Orthopedic Manufacturing Co. | 1978-11-08 | Traditional | PDF ↗ |
| K781839 | BONE CLAMP, ACE EXTERNAL | Ace Orthopedic Manufacturing Co. | 1978-11-08 | Traditional | PDF ↗ |
| K781841 | BAR, DISTRACTION | Ace Orthopedic Manufacturing Co. | 1978-11-08 | Traditional | PDF ↗ |
| K781793 | FRAME, UNIVERSAL DAY | B.G. Orthopedic Corp. | 1978-11-03 | Traditional | PDF ↗ |
| K770066 | TIBIAL COMPRESSION FRAM FOR FRACTURES | Richard F. Kronner, M.D. | 1977-03-30 | Traditional | PDF ↗ |
| K770388 | FRACTURE REDUCTION SYS., MODEL OR 1001 | Sisan Assoc. | 1977-03-14 | Traditional | PDF ↗ |
| K761088 | DEPUY MODIFIED SKELETAL TRACTION PIN | Depuy, Inc. | 1976-12-17 | Traditional | PDF ↗ |
Product code JEC · Class II · Orthopedic. Data: openFDA.