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 |