The following data is part of a premarket notification filed by Medicrea Technologies with the FDA for Pass Spinal System.
| Device ID | K080099 |
| 510k Number | K080099 |
| Device Name: | PASS SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | MEDICREA TECHNOLOGIES 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb MEDICREA TECHNOLOGIES 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-14 |
| Decision Date | 2008-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03613720293828 | K080099 | 000 |