The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Mayfield Infinity Skull Clamp.
| Device ID | K051440 |
| 510k Number | K051440 |
| Device Name: | MAYFIELD INFINITY SKULL CLAMP |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | INTEGRA LIFESCIENCES CORP. 311C ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Contact | Donna R Wallace |
| Correspondent | Donna R Wallace INTEGRA LIFESCIENCES CORP. 311C ENTERPRISE DRIVE 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 | 2005-06-02 |
| Decision Date | 2005-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M268419C12011 | K051440 | 000 |
| M26841A15141 | K051440 | 000 |
| M26841A15151 | K051440 | 000 |
| M26841B15161 | K051440 | 000 |
| M268421A11121 | K051440 | 000 |
| M268421A11171 | K051440 | 000 |
| M268421A11241 | K051440 | 000 |
| M268421B11271 | K051440 | 000 |
| M268431A11171 | K051440 | 000 |
| M268GS1111 | K051440 | 000 |
| M26841A14801 | K051440 | 000 |
| M26841A14761 | K051440 | 000 |
| M268419C12421 | K051440 | 000 |
| M26841A12261 | K051440 | 000 |
| M26841A13111 | K051440 | 000 |
| M26841A13121 | K051440 | 000 |
| M26841A13971 | K051440 | 000 |
| M26841A13981 | K051440 | 000 |
| M26841A14161 | K051440 | 000 |
| M26841A1416A1 | K051440 | 000 |
| M26841A14171 | K051440 | 000 |
| M268GS1131 | K051440 | 000 |
| M268GS1431 | K051440 | 000 |
| M268S419A12401 | K051440 | 000 |
| M268S419A12431 | K051440 | 000 |
| M268S419A12501 | K051440 | 000 |
| M268S419A12071 | K051440 | 000 |
| M268S419A12081 | K051440 | 000 |
| M268S419A12091 | K051440 | 000 |
| M268S419A12341 | K051440 | 000 |
| M268S419B12041 | K051440 | 000 |
| M268S419B12051 | K051440 | 000 |
| M268S419A12391 | K051440 | 000 |
| M268S419A12381 | K051440 | 000 |
| M268GS8361 | K051440 | 000 |
| M268GS9371 | K051440 | 000 |
| M268GS9381 | K051440 | 000 |
| M268S419A12031 | K051440 | 000 |
| M268S419A12321 | K051440 | 000 |
| M268S419A12331 | K051440 | 000 |
| M268S419A12351 | K051440 | 000 |
| M268S419A12361 | K051440 | 000 |
| M268S419A12371 | K051440 | 000 |
| M268S419B12061 | K051440 | 000 |