The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Dupuy Cement Restrictor Trials & Instr..
| Device ID | K800894 |
| 510k Number | K800894 |
| Device Name: | DUPUY CEMENT RESTRICTOR TRIALS & INSTR. |
| Classification | Nail, Fixation, Bone |
| Applicant | DEPUY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JDS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-18 |
| Decision Date | 1980-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295174493 | K800894 | 000 |
| 10603295174332 | K800894 | 000 |
| 10603295174349 | K800894 | 000 |
| 10603295174356 | K800894 | 000 |
| 10603295174363 | K800894 | 000 |
| 10603295174370 | K800894 | 000 |
| 10603295174387 | K800894 | 000 |
| 10603295174462 | K800894 | 000 |
| 10603295174486 | K800894 | 000 |
| 10603295174325 | K800894 | 000 |