The following data is part of a premarket notification filed by Cohort Medical Products Group, Inc. with the FDA for Cannulated Bone Screw.
| Device ID | K943474 |
| 510k Number | K943474 |
| Device Name: | CANNULATED BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | COHORT MEDICAL PRODUCTS GROUP, INC. 25590 SEABOARD LN. Hayward, CA 94545 |
| Contact | Mark Urbanski |
| Correspondent | Mark Urbanski COHORT MEDICAL PRODUCTS GROUP, INC. 25590 SEABOARD LN. Hayward, CA 94545 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-19 |
| Decision Date | 1994-10-14 |