The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Cemented Calcar Hip System.
| Device ID | K013490 |
| 510k Number | K013490 |
| Device Name: | CEMENTED CALCAR HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Joanna Droege |
| Correspondent | Joanna Droege ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-22 |
| Decision Date | 2002-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912081740 | K013490 | 000 |
| 00888912081627 | K013490 | 000 |
| 00888912081641 | K013490 | 000 |
| 00888912081658 | K013490 | 000 |
| 00888912081665 | K013490 | 000 |
| 00888912081672 | K013490 | 000 |
| 00888912081689 | K013490 | 000 |
| 00888912081702 | K013490 | 000 |
| 00888912081719 | K013490 | 000 |
| 00888912081726 | K013490 | 000 |
| 00888912081733 | K013490 | 000 |
| 00888912081610 | K013490 | 000 |