The following data is part of a premarket notification filed by Robert Reid Inc. with the FDA for Kapss Spinal System.
| Device ID | K093833 |
| 510k Number | K093833 |
| Device Name: | KAPSS SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | ROBERT REID INC. 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
| Contact | Karen E Warden |
| Correspondent | Karen E Warden ROBERT REID INC. 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-14 |
| Decision Date | 2010-10-15 |
| Summary: | summary |