The following data is part of a premarket notification filed by Advanced Medical Technologies Ag with the FDA for Art Posterior Spinal System.
Device ID | K033150 |
510k Number | K033150 |
Device Name: | ART POSTERIOR SPINAL SYSTEM |
Classification | Orthosis, Spinal Pedicle Fixation |
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 | MNI |
Subsequent Product Code | KWP |
Subsequent Product Code | MNH |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-30 |
Decision Date | 2004-03-01 |
Summary: | summary |