ORTHOSORB(R) ABSORBABLE PIN
FDA 510(k) clearance K901456 · decided 1990-08-15
Clearance details
- K-number
- K901456
- Device name
- ORTHOSORB(R) ABSORBABLE PIN
- Applicant
- Johnson & Johnson International
- Decision
- Substantially Equivalent
- Date received
- 1990-03-27
- Decision date
- 1990-08-15
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- OVZ
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Braintree, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ORTHOSORB LS (K140625) | Biomet, Inc. | 2014-04-18 |
| ORTHOSORB RESORBABLE PINS (K111077) | DePuy Orthopaedics, Inc. | 2011-07-12 |
Recalls involving this device
No recalls on record reference this clearance.