The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for Life Spine Metatarsal Hemi Implant.
| Device ID | K161279 |
| 510k Number | K161279 |
| Device Name: | Life Spine Metatarsal Hemi Implant |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| 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 | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-06 |
| Decision Date | 2017-02-01 |
| Summary: | summary |