The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Mayfield Mr/ct Skull Clamp, Model 4-0-a-1104.
| Device ID | K050319 |
| 510k Number | K050319 |
| Device Name: | MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | INTEGRA LIFESCIENCES CORP. 4900 CHARLEMAR DRIVE, BUILDING A Cincinatti, OH 45227 |
| Contact | Charles E Dinkler Ii |
| Correspondent | Charles E Dinkler Ii INTEGRA LIFESCIENCES CORP. 4900 CHARLEMAR DRIVE, BUILDING A Cincinatti, OH 45227 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-09 |
| Decision Date | 2005-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M268GS4221 | K050319 | 000 |
| M268428A10401 | K050319 | 000 |
| M268428A10351 | K050319 | 000 |
| M268428A10311 | K050319 | 000 |
| M268428A10281 | K050319 | 000 |
| M268428A10271 | K050319 | 000 |
| M268428A10231 | K050319 | 000 |
| M268428A10191 | K050319 | 000 |
| M268428A10141 | K050319 | 000 |
| M268428A10121 | K050319 | 000 |
| M268428A10111 | K050319 | 000 |
| M268428A10101 | K050319 | 000 |
| M268428A10421 | K050319 | 000 |
| M268428A10461 | K050319 | 000 |
| M268428A10491 | K050319 | 000 |
| M268439A10431 | K050319 | 000 |
| M268437B10861 | K050319 | 000 |
| M268437B10851 | K050319 | 000 |
| M268437A11371 | K050319 | 000 |
| M268437A10951 | K050319 | 000 |
| M268428C10001 | K050319 | 000 |
| M268428B10341 | K050319 | 000 |
| M268428A2010S1 | K050319 | 000 |
| M268428A2010L1 | K050319 | 000 |
| M268428A10711 | K050319 | 000 |
| M268428A10601 | K050319 | 000 |
| M268428A10011 | K050319 | 000 |