Product code LRN
- Device name
- Wire, Surgical
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3030
- 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 |
|---|---|---|---|
| K002755 | NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE | T. Korossurgical Instruments Corp. | 2000-12-04 |
| K990355 | STAINLESS STEEL SOFT SUTURE WIRE | Bregma International Trading Company , Ltd. | 1999-07-08 |
| K971682 | J-FX CERCLAGE SYSTEM | Johnson & Johnson Professionals, Inc. | 1997-06-27 |
| K952783 | OXBORO-MEDICAL PIN COVERS | Oxboro Medical Intl., Inc. | 1995-09-15 |
| K942603 | ORTHOPAEDIC WIRES | Acu Med, Inc. | 1994-11-09 |
| K900926 | TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS) | Howmedica Corp. | 1990-04-23 |
| K892651 | SONGER WIRING SYSTEM | Danek Medical, Inc. | 1989-07-25 |
| K864375 | TYPE 316L COTTER WIRE | Winn Hirsch & Assoc. | 1987-05-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613154345519 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613154490288 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613154490271 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613154490264 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613154490257 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613154490240 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613154379514 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613154379507 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613154379491 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613154379484 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613154379477 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613154379460 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613154379453 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613154345533 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613154345526 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613153068334 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613154345502 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613154345496 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613154345489 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613154345472 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613154345465 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613153068426 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613153068419 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613153068402 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613153068396 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613153068389 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613153068372 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613153068365 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613153068358 | VariAx | Stryker GmbH | 2015-09-24 |
| 07613153068341 | VariAx | Stryker GmbH | 2015-09-24 |