The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Press-fit Flared Shell.
| Device ID | K960633 |
| 510k Number | K960633 |
| Device Name: | PRESS-FIT FLARED SHELL |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | ENCORE ORTHOPEDICS, INC. 8900 SHOAL CREEK BLVD., BLDG. 300 Austin, TX 78757 |
| Contact | Ashley M Bock |
| Correspondent | Ashley M Bock ENCORE ORTHOPEDICS, INC. 8900 SHOAL CREEK BLVD., BLDG. 300 Austin, TX 78757 |
| Product Code | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-14 |
| Decision Date | 1996-10-01 |
| Summary: | summary |