The following data is part of a premarket notification filed by Medicrea International with the FDA for Pass Lp Spinal.
| Device ID | K112736 |
| 510k Number | K112736 |
| Device Name: | PASS LP SPINAL |
| Classification | Cerclage, Fixation |
| Applicant | MEDICREA INTERNATIONAL 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | J D Webb |
| Correspondent | J D Webb MEDICREA INTERNATIONAL 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-20 |
| Decision Date | 2012-02-01 |
| Summary: | summary |