DARWIN KNEE SYSTEM (TC3)
FDA 510(k) clearance K952830 · decided 1996-01-18
Clearance details
- K-number
- K952830
- Device name
- DARWIN KNEE SYSTEM (TC3)
- Applicant
- Johnson & Johnson Professionals, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1995-06-20
- Decision date
- 1996-01-18
- Days to decision
- 212 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Raritan, NJ, US
- Third-party review
- No
- Expedited review
- No
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