The following data is part of a premarket notification filed by U&i Corp., America with the FDA for U&i, Optima, Spinal System.
| Device ID | K031585 |
| 510k Number | K031585 |
| Device Name: | U&I, OPTIMA, SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | U&I CORP., AMERICA 6132 SOUTH 380 WEST, Murray, UT 84107 -6988 |
| Contact | Patrick Moore |
| Correspondent | Patrick Moore U&I CORP., AMERICA 6132 SOUTH 380 WEST, Murray, UT 84107 -6988 |
| Product Code | MNH |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-21 |
| Decision Date | 2003-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800015932844 | K031585 | 000 |
| 08800015932837 | K031585 | 000 |
| 08800015932752 | K031585 | 000 |