The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Mayfield Radiolucent Disposable Skull Pins.
| Device ID | K071458 |
| 510k Number | K071458 |
| Device Name: | MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Donna Wallace |
| Correspondent | Donna Wallace INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-25 |
| Decision Date | 2007-06-13 |
| Summary: | summary |