Submission Details
| 510(k) Number | K190904 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 08, 2019 |
| Decision Date | August 28, 2019 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
Conformis BeneFIT Hip System
Aug 2019
Decision
142d
Days
Class 2
Risk
About This 510(k) Submission
K190904 is an FDA 510(k) clearance for the Conformis BeneFIT Hip System, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Conformis, Inc. (Billerica, US). The FDA issued a Cleared decision on August 28, 2019, 142 days after receiving the submission on April 8, 2019. 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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