The following data is part of a premarket notification filed by Spinecraft Llc with the FDA for Apex Spine System W/ Cocr Rods.
| Device ID | K102488 |
| 510k Number | K102488 |
| Device Name: | APEX SPINE SYSTEM W/ COCR RODS |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SPINECRAFT LLC 2215 ENTERPRISE DRIVE SUITE 1504 Westchester, IL 60154 |
| Contact | Ami Akallal-asaad |
| Correspondent | Ami Akallal-asaad SPINECRAFT LLC 2215 ENTERPRISE DRIVE SUITE 1504 Westchester, IL 60154 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| 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 | 2010-08-31 |
| Decision Date | 2010-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00193082004384 | K102488 | 000 |
| 00193082004223 | K102488 | 000 |
| 00193082004216 | K102488 | 000 |
| 00193082004209 | K102488 | 000 |
| 00193082004193 | K102488 | 000 |
| 00193082004186 | K102488 | 000 |
| 00193082004179 | K102488 | 000 |
| 00193082004162 | K102488 | 000 |
| 00193082004155 | K102488 | 000 |
| 00193082004148 | K102488 | 000 |
| 00193082004131 | K102488 | 000 |
| 00193082004124 | K102488 | 000 |
| 00193082004117 | K102488 | 000 |
| 00193082004100 | K102488 | 000 |
| 00193082004230 | K102488 | 000 |
| 00193082004247 | K102488 | 000 |
| 00193082004377 | K102488 | 000 |
| 00193082004360 | K102488 | 000 |
| 00193082004353 | K102488 | 000 |
| 00193082004346 | K102488 | 000 |
| 00193082004339 | K102488 | 000 |
| 00193082004322 | K102488 | 000 |
| 00193082004315 | K102488 | 000 |
| 00193082004308 | K102488 | 000 |
| 00193082004292 | K102488 | 000 |
| 00193082004285 | K102488 | 000 |
| 00193082004278 | K102488 | 000 |
| 00193082004261 | K102488 | 000 |
| 00193082004254 | K102488 | 000 |
| 00193082004094 | K102488 | 000 |