The following data is part of a premarket notification filed by Atlas Spine, Inc. with the FDA for V3 Segmental Plating System.
| Device ID | K182418 |
| 510k Number | K182418 |
| Device Name: | V3 Segmental Plating System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Atlas Spine, Inc. 1555 Jupiter Park Drive, Suite 1 Jupiter, FL 33458 |
| Contact | Thomas Smith |
| Correspondent | Thomas Smith Atlas Spine, Inc. 1555 Jupiter Park Drive, Suite 1 Jupiter, FL 33458 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-05 |
| Decision Date | 2018-11-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M68111210400160 | K182418 | 000 |
| M68111210500190 | K182418 | 000 |
| M68111210500180 | K182418 | 000 |
| M68111210500170 | K182418 | 000 |
| M68111210500160 | K182418 | 000 |
| M68111210500150 | K182418 | 000 |
| M68111210500140 | K182418 | 000 |
| M68111210500130 | K182418 | 000 |
| M68111210500120 | K182418 | 000 |
| M68111210500110 | K182418 | 000 |
| M68111210500100 | K182418 | 000 |
| M68111210500090 | K182418 | 000 |
| M68111210500200 | K182418 | 000 |
| M68111210100090 | K182418 | 000 |
| M68111210100110 | K182418 | 000 |
| M68111210400140 | K182418 | 000 |
| M68111210400120 | K182418 | 000 |
| M68111210300160 | K182418 | 000 |
| M68111210300140 | K182418 | 000 |
| M68111210300120 | K182418 | 000 |
| M68111210200160 | K182418 | 000 |
| M68111210200140 | K182418 | 000 |
| M68111210200120 | K182418 | 000 |
| M68111210100170 | K182418 | 000 |
| M68111210100150 | K182418 | 000 |
| M68111210100130 | K182418 | 000 |
| M68111210500080 | K182418 | 000 |