K990712 is an FDA 510(k) clearance for the OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM. This device is classified as a Prosthesis, Shoulder, Humeral (bipolar Hemi-shoulder) Metal/polymer, Cemented Or Uncemented (Class III - Premarket Approval, product code MJT).
Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on July 20, 1999, 138 days after receiving the submission on March 4, 1999.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K990712 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1999 |
| Decision Date | July 20, 1999 |
| Days to Decision | 138 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MJT — Prosthesis, Shoulder, Humeral (bipolar Hemi-shoulder) Metal/polymer, Cemented Or Uncemented |
| Device Class | Class III - Premarket Approval |