MAYFIELD INFINITY SKULL CLAMP

Holder, Head, Neurosurgical (skull Clamp)

INTEGRA LIFESCIENCES CORP.

The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Mayfield Infinity Skull Clamp.

Pre-market Notification Details

Device IDK051440
510k NumberK051440
Device Name:MAYFIELD INFINITY SKULL CLAMP
ClassificationHolder, Head, Neurosurgical (skull Clamp)
Applicant INTEGRA LIFESCIENCES CORP. 311C ENTERPRISE DRIVE Plainsboro,  NJ  08536
ContactDonna R Wallace
CorrespondentDonna R Wallace
INTEGRA LIFESCIENCES CORP. 311C ENTERPRISE DRIVE Plainsboro,  NJ  08536
Product CodeHBL  
CFR Regulation Number882.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-02
Decision Date2005-09-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

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