The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Foundation Glenoid Component.
| Device ID | K960906 |
| 510k Number | K960906 |
| Device Name: | FOUNDATION GLENOID COMPONENT |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | ENCORE ORTHOPEDICS, INC. 8900 SHOAL CREEK BLVD., BLDG. 300 Austin, TX 78757 |
| Contact | Ashely M Bock |
| Correspondent | Ashely M Bock ENCORE ORTHOPEDICS, INC. 8900 SHOAL CREEK BLVD., BLDG. 300 Austin, TX 78757 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-05 |
| Decision Date | 1996-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912143134 | K960906 | 000 |
| 00888912143103 | K960906 | 000 |
| 00888912143158 | K960906 | 000 |
| 00888912143165 | K960906 | 000 |
| 00888912143189 | K960906 | 000 |
| 00888912143196 | K960906 | 000 |
| 00888912143202 | K960906 | 000 |
| 00888912143226 | K960906 | 000 |
| 00888912143233 | K960906 | 000 |
| 00888912143110 | K960906 | 000 |
| 00888912024099 | K960906 | 000 |