The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Cross Medical Bone Plate System/ Cm Bone Plate System/cross Ti Bone Plate System.
| Device ID | K961320 |
| 510k Number | K961320 |
| Device Name: | CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | BUCKMAN CO., INC. 100S BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 100S BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-05 |
| Decision Date | 1998-06-25 |
| Summary: | summary |