The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Osteomed Cranial Flap Fixation System.
Device ID | K022277 |
510k Number | K022277 |
Device Name: | OSTEOMED CRANIAL FLAP FIXATION SYSTEM |
Classification | Plate, Cranioplasty, Preformed, Non-alterable |
Applicant | OSTEOMED CORP. 3750 REALTY RD. Addison, TX 75001 -4311 |
Contact | Dawn T Holdeman |
Correspondent | Dawn T Holdeman OSTEOMED CORP. 3750 REALTY RD. Addison, TX 75001 -4311 |
Product Code | GXN |
CFR Regulation Number | 882.5330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-15 |
Decision Date | 2003-04-01 |
Summary: | summary |