THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #)
FDA 510(k) clearance K021970 · decided 2002-07-12
Clearance details
- K-number
- K021970
- Device name
- THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #)
- Applicant
- Implex Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-06-17
- Decision date
- 2002-07-12
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- 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.