The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Mayfield Skull Clamp.
| Device ID | K120633 |
| 510k Number | K120633 |
| Device Name: | MAYFIELD SKULL CLAMP |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Lindsay Mignone |
| Correspondent | Lindsay Mignone 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 | 2012-03-01 |
| Decision Date | 2012-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M268GS9711 | K120633 | 000 |
| M268GS9701 | K120633 | 000 |
| M268454A10901 | K120633 | 000 |