IMPLEX CONTINUUM KNEE - HEDROCEL TIBIAL SPACERS
FDA 510(k) clearance K982302 · decided 1998-07-31
Clearance details
- K-number
- K982302
- Device name
- IMPLEX CONTINUUM KNEE - HEDROCEL TIBIAL SPACERS
- Applicant
- Implex Corp.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1998-07-01
- Decision date
- 1998-07-31
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.