THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX)
FDA 510(k) clearance K012095 · decided 2001-07-26
Clearance details
- K-number
- K012095
- Device name
- THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX)
- Applicant
- Implex Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-05
- Decision date
- 2001-07-26
- Days to decision
- 21 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Implex Corp.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.