The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Sterile Radiolucent Skull Pins.
| Device ID | K122225 |
| 510k Number | K122225 |
| Device Name: | STERILE RADIOLUCENT SKULL PINS |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Contact | Alexander Schwiersch |
| Correspondent | Alexander Schwiersch BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-25 |
| Decision Date | 2013-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481004767 | K122225 | 000 |