Medline ReNewal Reprocessed Stryker External Fixation Devices
FDA 510(k) clearance K163028 · decided 2016-12-28
Clearance details
- K-number
- K163028
- Device name
- Medline ReNewal Reprocessed Stryker External Fixation Devices
- Applicant
- Surgical Instrument Service and Savings, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-10-31
- Decision date
- 2016-12-28
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- JEC
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Redmond, OR, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Surgical Instrument Service and Savings
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SteriTrak (K203605) | Arbutus Medical, Inc. | 2021-04-23 |
| Anjon Bremer Halo System (K193256) | Anjon Holdings, LLC | 2020-03-02 |
| DigiFix Sterile Kit (K192465) | Virak Orthopedics, LLC | 2019-10-10 |
| PIP Fix (K181192) | Hand Biomechanics Lab, Inc. | 2018-10-22 |
| Anjon Bremer Halo System (K171863) | Anjon Holdings, LLC | 2018-03-19 |
| DIGIFIX EXTERNAL FIXATION SYSTEM (K132731) | Virak Orthopedic Research, LLC | 2014-01-10 |
| HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX (K102885) | Stryker Corp. | 2011-01-14 |
| LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X (K082679) | Sintea Biotech, Inc. | 2009-04-07 |
| F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE (K072432) | Hand Biomechanics Lab, Inc. | 2008-01-09 |
| SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP (K071476) | Synthes (Usa) | 2007-08-24 |
| KLSA MARTIN HAND DISTRACTOR (K042066) | KLS-Martin L.P. | 2004-08-25 |
| FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM (K032427) | Meridan Medical | 2003-10-09 |
Recalls involving this device
No recalls on record reference this clearance.