DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
FDA 510(k) clearance K141385 · decided 2015-03-27
Clearance details
- K-number
- K141385
- Device name
- DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
- Applicant
- Depuy Synthes Companies of Johnson & Johnson
- Decision
- Substantially Equivalent
- Date received
- 2014-05-27
- Decision date
- 2015-03-27
- Days to decision
- 304 days
- Clearance type
- Traditional
- Product code
- HBW
- Device class
- 2
- Regulation number
- 882.5360
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- West Chester, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair a recall (Z-1238-2024) | Synthes (USA) Products LLC | 2024-03-01 |