The following data is part of a premarket notification filed by Medicrea Technologies with the FDA for Impix Spacer.
Device ID | K072226 |
510k Number | K072226 |
Device Name: | IMPIX SPACER |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
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 | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-08-10 |
Decision Date | 2007-12-10 |
Summary: | summary |