The following data is part of a premarket notification filed by Spinal Usa with the FDA for Reform Pedicle Screw System.
| Device ID | K130279 |
| 510k Number | K130279 |
| Device Name: | REFORM PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SPINAL USA 4628 NORTHPARK DRIVE Colorado Springs, MS 39208 |
| Contact | Meredith May |
| Correspondent | Meredith May SPINAL USA 4628 NORTHPARK DRIVE Colorado Springs, MS 39208 |
| 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 | 2013-02-05 |
| Decision Date | 2013-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815362027356 | K130279 | 000 |
| 00815362027851 | K130279 | 000 |
| 00815362027868 | K130279 | 000 |
| 00815362027875 | K130279 | 000 |
| 00815362027882 | K130279 | 000 |
| 00815362027899 | K130279 | 000 |
| 00840019901833 | K130279 | 000 |
| 00840019901840 | K130279 | 000 |
| 00840019901857 | K130279 | 000 |
| 00815362027844 | K130279 | 000 |
| 00815362027837 | K130279 | 000 |
| 00815362027820 | K130279 | 000 |
| 00815362027424 | K130279 | 000 |
| 00815362027431 | K130279 | 000 |
| 00815362027448 | K130279 | 000 |
| 00815362027455 | K130279 | 000 |
| 00815362027462 | K130279 | 000 |
| 00815362027479 | K130279 | 000 |
| 00815362027806 | K130279 | 000 |
| 00815362027813 | K130279 | 000 |
| 00840019901864 | K130279 | 000 |
| 00840019901871 | K130279 | 000 |
| 00840019902038 | K130279 | 000 |
| 00840019902045 | K130279 | 000 |
| 00840019902052 | K130279 | 000 |
| 00840019902069 | K130279 | 000 |
| 00840019902076 | K130279 | 000 |
| 00840019902083 | K130279 | 000 |
| 00840019902090 | K130279 | 000 |
| 00815362024034 | K130279 | 000 |
| 00840019902021 | K130279 | 000 |
| 00840019902014 | K130279 | 000 |
| 00840019902007 | K130279 | 000 |
| 00840019901888 | K130279 | 000 |
| 00840019901895 | K130279 | 000 |
| 00840019901901 | K130279 | 000 |
| 00840019901918 | K130279 | 000 |
| 00840019901949 | K130279 | 000 |
| 00840019901956 | K130279 | 000 |
| 00840019901987 | K130279 | 000 |
| 00840019901994 | K130279 | 000 |
| 00815362029695 | K130279 | 000 |