The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Modification To: Mayfield Radiolucent Skull Pins, Model 4-0-a-2020.
| Device ID | K053045 |
| 510k Number | K053045 |
| Device Name: | MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 |
| 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 | 2005-10-28 |
| Decision Date | 2005-11-21 |
| Summary: | summary |