Submission Details
| 510(k) Number | K121308 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 01, 2012 |
| Decision Date | July 30, 2012 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
HIP SYSTEMS
Jul 2012
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K121308 is an FDA 510(k) clearance for the HIP SYSTEMS, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Howmedica Osteonics Corp. (Malwah, US). The FDA issued a Cleared decision on July 30, 2012, 90 days after receiving the submission on May 1, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.
Device Classification
| Product Code | LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3358 |
Manufacturer
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