The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Halifax Plus Interlaminar Clamp System.
| Device ID | K962314 |
| 510k Number | K962314 |
| Device Name: | HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Charles Ryan |
| Correspondent | Charles Ryan OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-17 |
| Decision Date | 1996-12-09 |
| Summary: | summary |