The following data is part of a premarket notification filed by Medicrea with the FDA for Passmed Spinal System.
| Device ID | K032094 |
| 510k Number | K032094 |
| Device Name: | PASSMED SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-07 |
| Decision Date | 2003-11-14 |
| Summary: | summary |