The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Peek Craniofix.
| Device ID | K091692 |
| 510k Number | K091692 |
| Device Name: | AESCULAP PEEK CRANIOFIX |
| Classification | Cover, Burr Hole |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | GXR |
| CFR Regulation Number | 882.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-10 |
| Decision Date | 2010-08-12 |
| Summary: | summary |