MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS

Holder, Head, Neurosurgical (skull Clamp)

INTEGRA LIFESCIENCES CORPORATION

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.

Pre-market Notification Details

Device IDK072208
510k NumberK072208
Device Name:MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
ClassificationHolder, Head, Neurosurgical (skull Clamp)
Applicant INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro,  NJ  08536
ContactHelder A Sousa
CorrespondentHelder A Sousa
INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro,  NJ  08536
Product CodeHBL  
CFR Regulation Number882.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-08
Decision Date2007-09-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

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