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 |