The following data is part of a premarket notification filed by Stryker Osteonics with the FDA for Osteo 5.0mm Cannulated Screw System.
| Device ID | K983006 |
| 510k Number | K983006 |
| Device Name: | OSTEO 5.0MM CANNULATED SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | STRYKER OSTEONICS 59 ROUTE 17 Allendale,, NJ 07401 -1677 |
| Contact | Elizabeth A Staub |
| Correspondent | Elizabeth A Staub STRYKER OSTEONICS 59 ROUTE 17 Allendale,, NJ 07401 -1677 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-28 |
| Decision Date | 1998-11-23 |
| Summary: | summary |