Submission Details
| 510(k) Number | K222632 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 31, 2022 |
| Decision Date | October 21, 2022 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
UHR Bipolar Implants, Restoration GAP II Implants
Oct 2022
Decision
51d
Days
Class 2
Risk
About This 510(k) Submission
K222632 is an FDA 510(k) clearance for the UHR Bipolar Implants, Restoration GAP II Implants, a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II — Special Controls, product code KWL), submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on October 21, 2022, 51 days after receiving the submission on August 31, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.
Device Classification
| Product Code | KWL — Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3360 |
Manufacturer
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Malwah, NJ · US
Margaret Klippel
31 submissions
31 cleared
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