The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Primaloc Cemented Hip System.
| Device ID | K962448 |
| 510k Number | K962448 |
| Device Name: | PRIMALOC CEMENTED HIP SYSTEM |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | ORTHO DEVELOPMENT CORP. 106 WEST 12200 SOUTH Draper, UT 84020 |
| Contact | Michelle M Perry |
| Correspondent | Michelle M Perry ORTHO DEVELOPMENT CORP. 106 WEST 12200 SOUTH Draper, UT 84020 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-24 |
| Decision Date | 1996-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822409012992 | K962448 | 000 |
| 00822409012800 | K962448 | 000 |
| 00822409012817 | K962448 | 000 |
| 00822409012824 | K962448 | 000 |
| 00822409012831 | K962448 | 000 |
| 00822409012848 | K962448 | 000 |
| 00822409012855 | K962448 | 000 |
| 00822409012862 | K962448 | 000 |
| 00822409012879 | K962448 | 000 |
| 00822409012886 | K962448 | 000 |
| 00822409012947 | K962448 | 000 |
| 00822409012954 | K962448 | 000 |
| 00822409012961 | K962448 | 000 |
| 00822409012978 | K962448 | 000 |
| 00822409012985 | K962448 | 000 |
| 00822409012794 | K962448 | 000 |