The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Modified Profile Hip Pmma Cement Spacer.
| Device ID | K871510 |
| 510k Number | K871510 |
| Device Name: | MODIFIED PROFILE HIP PMMA CEMENT SPACER |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Steven J Wentworth |
| Correspondent | Steven J Wentworth DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-15 |
| Decision Date | 1987-05-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295034568 | K871510 | 000 |
| 10603295034452 | K871510 | 000 |
| 10603295034469 | K871510 | 000 |
| 10603295034476 | K871510 | 000 |
| 10603295034483 | K871510 | 000 |
| 10603295034490 | K871510 | 000 |
| 10603295034506 | K871510 | 000 |
| 10603295034513 | K871510 | 000 |
| 10603295034520 | K871510 | 000 |
| 10603295034537 | K871510 | 000 |
| 10603295034544 | K871510 | 000 |
| 10603295034551 | K871510 | 000 |
| 10603295034445 | K871510 | 000 |