The following data is part of a premarket notification filed by Medicrea with the FDA for Pass 2 Spinal System.
Device ID | K062136 |
510k Number | K062136 |
Device Name: | PASS 2 SPINAL SYSTEM |
Classification | Orthosis, Spinal Pedicle Fixation |
Applicant | MEDICREA 1001 OAKWOOD BLVD Round Rock, TX 78681 |
Contact | J.d. Webb |
Correspondent | J.d. Webb MEDICREA 1001 OAKWOOD BLVD Round Rock, TX 78681 |
Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-07-26 |
Decision Date | 2006-10-06 |
Summary: | summary |