The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Mayfield Infinity Xr2 Skull Clamp.
| Device ID | K130389 |
| 510k Number | K130389 |
| Device Name: | MAYFIELD INFINITY XR2 SKULL CLAMP |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Janet Kay |
| Correspondent | Janet Kay INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-15 |
| Decision Date | 2013-04-23 |
| Summary: | summary |