The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Inserteo, Meta.-phal.&thumb Carpo-meta.
| Device ID | K771072 |
| 510k Number | K771072 |
| Device Name: | INSERTEO, META.-PHAL.&THUMB CARPO-META |
| Classification | Pusher, Socket |
| Applicant | DEPUY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HXO |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-06-14 |
| Decision Date | 1977-06-27 |