The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Crainfix 2 Titanium Clamp System.
| Device ID | K122353 |
| 510k Number | K122353 |
| Device Name: | CRAINFIX 2 TITANIUM CLAMP SYSTEM |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Denise Adams |
| Correspondent | Denise Adams AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-03 |
| Decision Date | 2012-08-30 |
| Summary: | summary |