The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Total Shoulder Prosthesis Polyethylene Glenoind Co.
| Device ID | K905580 |
| 510k Number | K905580 |
| Device Name: | TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | EXACTECH, INC. 2210 N.W. 28TH ST. Gainesville, FL 32605 |
| Contact | William Petty |
| Correspondent | William Petty EXACTECH, INC. 2210 N.W. 28TH ST. Gainesville, FL 32605 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-12 |
| Decision Date | 1991-03-12 |