The following data is part of a premarket notification filed by Cross Medical Products, Inc. with the FDA for Synergy Closed Variable Locking Screw (vls), Part Of The Cross Medical-synergy Anterior And Posterior Spinal Systems.
| Device ID | K974749 |
| 510k Number | K974749 |
| Device Name: | SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | CROSS MEDICAL PRODUCTS, INC. 5160-A BLAZER PKWY. SUITE A Dublin, OH 43017 -1339 |
| Contact | Phil Mellinger |
| Correspondent | Phil Mellinger CROSS MEDICAL PRODUCTS, INC. 5160-A BLAZER PKWY. SUITE A Dublin, OH 43017 -1339 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-19 |
| Decision Date | 1998-03-13 |
| Summary: | summary |