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.
Device ID | K072208 |
510k Number | K072208 |
Device Name: | MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS |
Classification | Holder, Head, Neurosurgical (skull Clamp) |
Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
Contact | Helder A Sousa |
Correspondent | Helder A Sousa INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
Product Code | HBL |
CFR Regulation Number | 882.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-08-08 |
Decision Date | 2007-09-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
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 |