The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Multi-axial Cross (mac) Connector.
| Device ID | K000965 |
| 510k Number | K000965 |
| Device Name: | MULTI-AXIAL CROSS (MAC) CONNECTOR |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Terry Sheridan Powell |
| Correspondent | Terry Sheridan Powell HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-27 |
| Decision Date | 2000-05-11 |