The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Mayfield Infinity Xr2 Skull Clamp, Model A-2114.
| Device ID | K090506 |
| 510k Number | K090506 |
| Device Name: | MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114 |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 4900 CHARLEMAR DR., BUILDING A Cincinnati, OH 45227 |
| Contact | Helder A Sousa |
| Correspondent | Helder A Sousa INTEGRA LIFESCIENCES CORPORATION 4900 CHARLEMAR DR., BUILDING A Cincinnati, OH 45227 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-25 |
| Decision Date | 2009-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M268S431A31141 | K090506 | 000 |
| M268439A10401 | K090506 | 000 |
| M268439A10381 | K090506 | 000 |
| M268439A10371 | K090506 | 000 |
| M268439A10361 | K090506 | 000 |
| M268439A10341 | K090506 | 000 |
| M268439A10331 | K090506 | 000 |
| M268439A10321 | K090506 | 000 |
| M268439A10311 | K090506 | 000 |
| M268439A10301 | K090506 | 000 |
| M268439A10211 | K090506 | 000 |
| M268439A10101 | K090506 | 000 |
| M268439A10031 | K090506 | 000 |
| M268439A10011 | K090506 | 000 |
| M268439A10411 | K090506 | 000 |
| M268439A10421 | K090506 | 000 |
| M268439A10441 | K090506 | 000 |
| M268GS9011 | K090506 | 000 |
| M268439A10731 | K090506 | 000 |
| M268439A10721 | K090506 | 000 |
| M268439A10711 | K090506 | 000 |
| M268439A10571 | K090506 | 000 |
| M268439A10561 | K090506 | 000 |
| M268439A10551 | K090506 | 000 |
| M268439A10531 | K090506 | 000 |
| M268439A10521 | K090506 | 000 |
| M268439A10511 | K090506 | 000 |
| M268439A10471 | K090506 | 000 |
| M268439A10461 | K090506 | 000 |
| M268439A10451 | K090506 | 000 |
| M268431A11641 | K090506 | 000 |