The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for The Cranial Fusion System.
| Device ID | K162266 |
| 510k Number | K162266 |
| Device Name: | The Cranial Fusion System |
| Classification | Posterior Cervical Screw System |
| Applicant | LIFE SPINE INC. 13951 S QUALITY DRIVE Huntley, IL 60142 |
| Contact | Randy Lewis |
| Correspondent | Randy Lewis LIFE SPINE INC. 13951 S QUALITY DRIVE Huntley, IL 60142 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-11 |
| Decision Date | 2017-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837085377 | K162266 | 000 |
| 00190837068936 | K162266 | 000 |
| 00190837068929 | K162266 | 000 |
| 00190837068912 | K162266 | 000 |
| 00190837068905 | K162266 | 000 |
| 00190837068899 | K162266 | 000 |
| 00190837068882 | K162266 | 000 |
| 00190837068875 | K162266 | 000 |
| 00190837068868 | K162266 | 000 |
| 00190837068851 | K162266 | 000 |
| 00190837068844 | K162266 | 000 |
| 00190837068837 | K162266 | 000 |
| 00190837068820 | K162266 | 000 |
| 00190837068813 | K162266 | 000 |
| 00190837068806 | K162266 | 000 |
| 00190837031404 | K162266 | 000 |
| 00190837031398 | K162266 | 000 |
| 00190837031381 | K162266 | 000 |
| 00190837085186 | K162266 | 000 |
| 00190837085193 | K162266 | 000 |
| 00190837085360 | K162266 | 000 |
| 00190837085353 | K162266 | 000 |
| 00190837085346 | K162266 | 000 |
| 00190837085339 | K162266 | 000 |
| 00190837085322 | K162266 | 000 |
| 00190837085315 | K162266 | 000 |
| 00190837085308 | K162266 | 000 |
| 00190837085292 | K162266 | 000 |
| 00190837085285 | K162266 | 000 |
| 00190837085278 | K162266 | 000 |
| 00190837085261 | K162266 | 000 |
| 00190837085254 | K162266 | 000 |
| 00190837085247 | K162266 | 000 |
| 00190837085230 | K162266 | 000 |
| 00190837085223 | K162266 | 000 |
| 00190837085216 | K162266 | 000 |
| 00190837085209 | K162266 | 000 |
| 00190837031374 | K162266 | 000 |