The following data is part of a premarket notification filed by Atlas Spine Inc. with the FDA for Apclo Pedicle Screw Systems.
| Device ID | K112759 |
| 510k Number | K112759 |
| Device Name: | APCLO PEDICLE SCREW SYSTEMS |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | ATLAS SPINE INC. 1555 JUPITER PARK DR., STE. 4 Jupiter, FL 33458 |
| Contact | Thomas G Smith |
| Correspondent | Thomas G Smith ATLAS SPINE INC. 1555 JUPITER PARK DR., STE. 4 Jupiter, FL 33458 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-22 |
| Decision Date | 2011-10-18 |
| Summary: | summary |