The following data is part of a premarket notification filed by Medicrea Technologies with the FDA for C-jaws Cervical Compressive Mini Frame.
Device ID | K062181 |
510k Number | K062181 |
Device Name: | C-JAWS CERVICAL COMPRESSIVE MINI FRAME |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | MEDICREA TECHNOLOGIES 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
Contact | J.d. Webb |
Correspondent | J.d. Webb MEDICREA TECHNOLOGIES 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
Product Code | KWP |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-07-31 |
Decision Date | 2007-01-16 |
Summary: | summary |