Submission Details
| 510(k) Number | K153345 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 19, 2015 |
| Decision Date | May 25, 2016 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
K153345 - Stryker Orthopaedics Hip Systems Labeling Update
(FDA 510(k) Clearance)
May 2016
Decision
188d
Days
Class 2
Risk
K153345 is an FDA 510(k) clearance for the Stryker Orthopaedics Hip Systems Labeling Update. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH).
Submitted by Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on May 25, 2016, 188 days after receiving the submission on November 19, 2015.
This device falls under the Orthopedic FDA 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 |
Similar Devices — LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
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