The following data is part of a premarket notification filed by Cohort Medical Products Group, Inc. with the FDA for Cohort(tm) Anterior Plate System (aps).
| Device ID | K950011 |
| 510k Number | K950011 |
| Device Name: | COHORT(TM) ANTERIOR PLATE SYSTEM (APS) |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | COHORT MEDICAL PRODUCTS GROUP, INC. 25590 SEABOARD LN. Hayward, CA 94545 |
| Contact | Mark Urbsnski |
| Correspondent | Mark Urbsnski COHORT MEDICAL PRODUCTS GROUP, INC. 25590 SEABOARD LN. Hayward, CA 94545 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-03 |
| Decision Date | 1995-11-06 |