K872454 is an FDA 510(k) clearance for the BIOMET MODULAR SHOULDER PROSTHESIS. This device is classified as a Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (Class II - Special Controls, product code KWT).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 27, 1987, 65 days after receiving the submission on June 23, 1987.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3650.
| 510(k) Number | K872454 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | June 23, 1987 |
| Decision Date | August 27, 1987 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KWT — Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3650 |