The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Mayfield Disposable And Reusable Titanium Skull Pins.
| Device ID | K072208 |
| 510k Number | K072208 |
| Device Name: | MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Helder A Sousa |
| Correspondent | Helder A Sousa 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 | 2007-08-08 |
| Decision Date | 2007-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M268SGS3191 | K072208 | 000 |
| M268A11201 | K072208 | 000 |
| M268A11211 | K072208 | 000 |
| M268A11221 | K072208 | 000 |
| M26841A14361 | K072208 | 000 |
| M268GS3181 | K072208 | 000 |
| M268GS3191 | K072208 | 000 |
| M268GS9181 | K072208 | 000 |
| M268SGS9181 | K072208 | 000 |
| M268S41A14361 | K072208 | 000 |
| M268SGS3181 | K072208 | 000 |
| M268A11191 | K072208 | 000 |