MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM
FDA 510(k) clearance K880826 · decided 1988-03-14
Clearance details
- K-number
- K880826
- Device name
- MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM
- Applicant
- Johnson & Johnson Professionals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-03-01
- Decision date
- 1988-03-14
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- KYK
- Device class
- 2
- Regulation number
- 888.3500
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Raynham, 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 |
|---|---|---|
| MODIFIED TOWNLEY UNICONDYLAR KNEE (K871118) | Depuy, Inc. | 1987-04-06 |
| SYNATOMIC VARIABLE FIT TIBIAL PLATEAU (K851341) | Depuy, Inc. | 1985-07-15 |
Recalls involving this device
No recalls on record reference this clearance.