The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Amc R Metacarpal Component.
| Device ID | K790793 |
| 510k Number | K790793 |
| Device Name: | AMC R METACARPAL COMPONENT |
| Classification | Prosthesis, Wrist, Carpal Lunate |
| Applicant | HOWMEDICA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KWN |
| CFR Regulation Number | 888.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-04-24 |
| Decision Date | 1979-06-22 |