The following data is part of a premarket notification filed by Advanced Biosearch Assn. with the FDA for Martin Laminar Osteosynthesis System.
| Device ID | K854770 |
| 510k Number | K854770 |
| Device Name: | MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | ADVANCED BIOSEARCH ASSN. 1700 ROCKVILLE PIKE SUITE 320 Rockville, MD 20852 |
| Contact | Jo Lyons |
| Correspondent | Jo Lyons ADVANCED BIOSEARCH ASSN. 1700 ROCKVILLE PIKE SUITE 320 Rockville, MD 20852 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-27 |
| Decision Date | 1986-02-11 |