The following data is part of a premarket notification filed by Advanced Medical Technologies Ag with the FDA for Wave D Cage.
Device ID | K121333 |
510k Number | K121333 |
Device Name: | WAVE D CAGE |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | ADVANCED MEDICAL TECHNOLOGIES AG 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
Contact | J.d. Webb |
Correspondent | J.d. Webb ADVANCED MEDICAL TECHNOLOGIES AG 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 | 2012-05-03 |
Decision Date | 2012-06-29 |