The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for The Plateau-lo Spacer System.
| Device ID | K172105 |
| 510k Number | K172105 |
| Device Name: | The Plateau-LO Spacer System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-12 |
| Decision Date | 2018-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837070373 | K172105 | 000 |
| 00190837082789 | K172105 | 000 |
| 00190837070281 | K172105 | 000 |
| 00190837070274 | K172105 | 000 |
| 00190837070267 | K172105 | 000 |
| 00190837070250 | K172105 | 000 |
| 00190837070243 | K172105 | 000 |
| 00190837070229 | K172105 | 000 |
| 00190837070212 | K172105 | 000 |
| 00190837070205 | K172105 | 000 |
| 00190837070199 | K172105 | 000 |
| 00190837070182 | K172105 | 000 |
| 00190837070175 | K172105 | 000 |
| 00190837070168 | K172105 | 000 |
| 00190837070151 | K172105 | 000 |
| 00190837070144 | K172105 | 000 |
| 00190837070137 | K172105 | 000 |
| 00190837070120 | K172105 | 000 |
| 00190837082796 | K172105 | 000 |
| 00190837082802 | K172105 | 000 |
| 00190837082819 | K172105 | 000 |
| 00190837070366 | K172105 | 000 |
| 00190837070359 | K172105 | 000 |
| 00190837070342 | K172105 | 000 |
| 00190837070335 | K172105 | 000 |
| 00190837070328 | K172105 | 000 |
| 00190837070311 | K172105 | 000 |
| 00190837070304 | K172105 | 000 |
| 00190837070298 | K172105 | 000 |
| 00190837070236 | K172105 | 000 |
| 00190837082895 | K172105 | 000 |
| 00190837082888 | K172105 | 000 |
| 00190837082871 | K172105 | 000 |
| 00190837082864 | K172105 | 000 |
| 00190837082857 | K172105 | 000 |
| 00190837082840 | K172105 | 000 |
| 00190837082833 | K172105 | 000 |
| 00190837082826 | K172105 | 000 |
| 00190837070113 | K172105 | 000 |