Product code JEC
- Device name
- Component, Traction, Invasive
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3040
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203605 | SteriTrak | Arbutus Medical, Inc. | 2021-04-23 |
| K193256 | Anjon Bremer Halo System | Anjon Holdings, LLC | 2020-03-02 |
| K192465 | DigiFix Sterile Kit | Virak Orthopedics, LLC | 2019-10-10 |
| K181192 | PIP Fix | Hand Biomechanics Lab, Inc. | 2018-10-22 |
| K171863 | Anjon Bremer Halo System | Anjon Holdings, LLC | 2018-03-19 |
| K163028 | Medline ReNewal Reprocessed Stryker External Fixation Devices | Surgical Instrument Service and Savings, Inc. | 2016-12-28 |
| K132731 | DIGIFIX EXTERNAL FIXATION SYSTEM | Virak Orthopedic Research, LLC | 2014-01-10 |
| 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 |
| K082679 | LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X | Sintea Biotech, Inc. | 2009-04-07 |
| K072432 | F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE | Hand Biomechanics Lab, Inc. | 2008-01-09 |
| K071476 | SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP | Synthes (Usa) | 2007-08-24 |
| K042066 | KLSA MARTIN HAND DISTRACTOR | KLS-Martin L.P. | 2004-08-25 |
| K032427 | FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM | Meridan Medical | 2003-10-09 |
| K031941 | HOFFMANN II COMPACT BALTIMORE COUPLING | Howmedica Osteonics Corp. | 2003-07-24 |
| K030519 | WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS | Hand Biomechanics Lab, Inc. | 2003-06-10 |
| K022676 | ORTHOGUARD AB ANTIMICROBIAL SLEEVE | Smith & Nephew, Inc. | 2002-09-23 |
| K022065 | SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X | Sintea Biotech, Inc. | 2002-08-06 |
| K012193 | AMC ANTIMICROBIAL PIN/WIRE SLEEVE | Smith & Nephew, Inc. | 2002-07-11 |
| K013818 | AUTOGENESIS AUTOMATOR, MODEL M1000 | Autogenesis, Inc. | 2001-12-05 |
| K003848 | HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST | Howmedica Osteonics Corp. | 2001-01-11 |
| K993099 | BREMER HALO SYSTEM TITANIUM SKULL PIN | Depuyacromed | 1999-12-15 |
| K991732 | CENTRAFIX EXTERNAL FIXATOR | Owandar Medical, Ltd. | 1999-05-21 |
| K984442 | AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 | Hand Biomechanics Lab, Inc. | 1999-02-12 |
| K981423 | AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000 | Autogenesis, Inc. | 1998-05-20 |
| K971755 | HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM | Howmedica Corp. | 1997-07-17 |
| K965029 | STABLELOC II EXTERNAL FIXATOR | Acu Med, Inc. | 1997-02-19 |
| K963614 | MONOTUBE CARBON TUBE | Howmedica Corp. | 1996-11-06 |
| K961916 | HOFFMANN II CARBON CONNECTING ROD | Howmedica, Inc. | 1996-08-01 |
| K961618 | MONOTUBE TUBE TO RING CLAMP | Howmedica Corp. | 1996-05-28 |
| K960782 | TITANIUM TUBE TO TUBE CLAMP | Synthes (Usa) | 1996-05-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327079241 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079272 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079302 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079333 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079395 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079401 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079449 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079470 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079500 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079524 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079562 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613154164134 | HOFFMANN | Stryker GmbH | 2016-09-24 |
| 10806378067341 | ACUMED | Acumed LLC | 2015-10-24 |
| 10705034341910 | BREMER | DEPUY SPINE, LLC | 2015-09-24 |
| 10705034243719 | BREMER | DEPUY SPINE, LLC | 2015-09-24 |
| 10705034341989 | BREMER | DEPUY SPINE, LLC | 2015-09-24 |
| 10705034341972 | BREMER | DEPUY SPINE, LLC | 2015-09-24 |
| 10705034341965 | BREMER HIFIX | DEPUY SPINE, LLC | 2015-09-24 |
| 10705034341958 | BREMER HALO CROWN | DEPUY SPINE, LLC | 2015-09-24 |
| 10705034341941 | BREMER HIFIX | DEPUY SPINE, LLC | 2015-09-24 |
| 10705034341934 | BREMER HALO CROWN | DEPUY SPINE, LLC | 2015-09-24 |
| 10705034341927 | BREMER | DEPUY SPINE, LLC | 2015-09-24 |
| 10705034245089 | BREMER | DEPUY SPINE, LLC | 2015-09-24 |
| 10705034341903 | BREMER HIFIX | DEPUY SPINE, LLC | 2015-09-24 |
| 10705034341897 | BREMER | DEPUY SPINE, LLC | 2015-09-24 |
| 10705034341880 | BREMER 3D HALO CROWN | DEPUY SPINE, LLC | 2015-09-24 |
| 10705034341750 | BREMER | DEPUY SPINE, LLC | 2015-09-24 |
| 10705034341743 | BREMER | DEPUY SPINE, LLC | 2015-09-24 |
| 10705034341736 | BREMER | DEPUY SPINE, LLC | 2015-09-24 |
| 10705034245096 | BREMER | DEPUY SPINE, LLC | 2015-09-24 |