Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments— 510(k) K152494
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K152494 for Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments, Substantially Equivalent on 2015-11-25. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Product code JWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3560
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code JWH
view allMore clearances from Zimmer, Inc.
view allAdverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K152494
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152494.
Data sourced from openFDA. This site is unofficial and independent of the FDA.