The following data is part of a premarket notification filed by Aesculap Implant System, Inc. with the FDA for Laminoplasty Plating System.
| Device ID | K090354 |
| 510k Number | K090354 |
| Device Name: | LAMINOPLASTY PLATING SYSTEM |
| Classification | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Applicant | AESCULAP IMPLANT SYSTEM, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle AESCULAP IMPLANT SYSTEM, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | NQW |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-11 |
| Decision Date | 2009-05-12 |
| Summary: | summary |