The following data is part of a premarket notification filed by Cross Medical Products, Inc. with the FDA for Synergy Ti Anterior Spinal System.
Device ID | K950709 |
510k Number | K950709 |
Device Name: | SYNERGY TI ANTERIOR SPINAL SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | CROSS MEDICAL PRODUCTS, INC. C/O BUCKMAN CO., INC. 1000 BURNETT AVENUE, STE. 450 Concord, CA 94520 |
Contact | David W Schlerf |
Correspondent | David W Schlerf CROSS MEDICAL PRODUCTS, INC. C/O BUCKMAN CO., INC. 1000 BURNETT AVENUE, STE. 450 Concord, CA 94520 |
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 | 1995-02-13 |
Decision Date | 1995-10-25 |