The following data is part of a premarket notification filed by Spinal Usa with the FDA for Vault Alif System.
Device ID | K130445 |
510k Number | K130445 |
Device Name: | VAULT ALIF SYSTEM |
Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Applicant | SPINAL USA 1001 OAKWOOD BLVD Round Rock, TX 78681 |
Contact | J.d. Webb |
Correspondent | J.d. Webb SPINAL USA 1001 OAKWOOD BLVD Round Rock, TX 78681 |
Product Code | OVD |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-02-21 |
Decision Date | 2013-04-25 |
Summary: | summary |