The following data is part of a premarket notification filed by Advanced Medical Technology, Inc. with the FDA for Distractable Wave Cage.
| Device ID | K083626 |
| 510k Number | K083626 |
| Device Name: | DISTRACTABLE WAVE CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | ADVANCED MEDICAL TECHNOLOGY, INC. 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb ADVANCED MEDICAL TECHNOLOGY, INC. 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-08 |
| Decision Date | 2009-10-19 |
| Summary: | summary |