The following data is part of a premarket notification filed by Scient'x with the FDA for Stella Cervical Plate.
Device ID | K052763 |
510k Number | K052763 |
Device Name: | STELLA CERVICAL PLATE |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | SCIENT'X 1001 OAKWOOD BLVD Round Rock, TX 78681 |
Contact | J. D. Webb |
Correspondent | J. D. Webb SCIENT'X 1001 OAKWOOD BLVD Round Rock, TX 78681 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-09-30 |
Decision Date | 2005-11-10 |
Summary: | summary |