The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Select Shoulder Offset Humeral Head Components.
| Device ID | K971715 |
| 510k Number | K971715 |
| Device Name: | SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Jacquelyn Hughes |
| Correspondent | Jacquelyn Hughes SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | KWS |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWT |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-09 |
| Decision Date | 1997-08-07 |
| Summary: | summary |