Submission Details
| 510(k) Number | K051844 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 07, 2005 |
| Decision Date | October 07, 2005 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
EQUATOR PLUS ACETABULAR CUP SYSTEM
Oct 2005
Decision
92d
Days
Class 2
Risk
About This 510(k) Submission
K051844 is an FDA 510(k) clearance for the EQUATOR PLUS ACETABULAR CUP SYSTEM, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish (Class II — Special Controls, product code MAY), submitted by Portland Orthopaedics Pty. , Ltd. (Stillwater, US). The FDA issued a Cleared decision on October 7, 2005, 92 days after receiving the submission on July 7, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.
Device Classification
| Product Code | MAY — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3353 |
Manufacturer
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