The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Self-centering Hip.
Device ID | K812672 |
510k Number | K812672 |
Device Name: | SELF-CENTERING HIP |
Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
Applicant | DEPUY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KWY |
CFR Regulation Number | 888.3390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-09-22 |
Decision Date | 1981-10-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10603295003298 | K812672 | 000 |
10603295003410 | K812672 | 000 |
10603295003427 | K812672 | 000 |
10603295003434 | K812672 | 000 |
10603295003441 | K812672 | 000 |
10603295003458 | K812672 | 000 |
10603295003465 | K812672 | 000 |
10603295003472 | K812672 | 000 |
10603295003489 | K812672 | 000 |
10603295003403 | K812672 | 000 |
10603295003397 | K812672 | 000 |
10603295003380 | K812672 | 000 |
10603295003304 | K812672 | 000 |
10603295003311 | K812672 | 000 |
10603295003328 | K812672 | 000 |
10603295003335 | K812672 | 000 |
10603295003342 | K812672 | 000 |
10603295003359 | K812672 | 000 |
10603295003366 | K812672 | 000 |
10603295003373 | K812672 | 000 |
10603295003496 | K812672 | 000 |
10603295003502 | K812672 | 000 |
10603295003625 | K812672 | 000 |
10603295003632 | K812672 | 000 |
10603295003649 | K812672 | 000 |
10603295003656 | K812672 | 000 |
10603295003663 | K812672 | 000 |
10603295003670 | K812672 | 000 |
10603295003687 | K812672 | 000 |
10603295003694 | K812672 | 000 |
10603295003618 | K812672 | 000 |
10603295003601 | K812672 | 000 |
10603295003595 | K812672 | 000 |
10603295003519 | K812672 | 000 |
10603295003526 | K812672 | 000 |
10603295003533 | K812672 | 000 |
10603295003540 | K812672 | 000 |
10603295003557 | K812672 | 000 |
10603295003564 | K812672 | 000 |
10603295003571 | K812672 | 000 |
10603295003588 | K812672 | 000 |
10603295003700 | K812672 | 000 |