The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for Hammertoe Correction System.
| Device ID | K171448 |
| 510k Number | K171448 |
| Device Name: | Hammertoe Correction System |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-17 |
| Decision Date | 2017-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837021498 | K171448 | 000 |
| 00190837069971 | K171448 | 000 |
| 00190837069964 | K171448 | 000 |
| 00190837069957 | K171448 | 000 |
| 00190837069940 | K171448 | 000 |
| 00190837069933 | K171448 | 000 |
| 00190837069926 | K171448 | 000 |
| 00190837069919 | K171448 | 000 |
| 00190837069902 | K171448 | 000 |
| 00190837069896 | K171448 | 000 |
| 00190837069889 | K171448 | 000 |
| 00190837069872 | K171448 | 000 |
| 00190837033101 | K171448 | 000 |
| 00190837069988 | K171448 | 000 |
| 00190837069995 | K171448 | 000 |
| 00190837021221 | K171448 | 000 |
| 00190837070106 | K171448 | 000 |
| 00190837070090 | K171448 | 000 |
| 00190837070083 | K171448 | 000 |
| 00190837070076 | K171448 | 000 |
| 00190837070069 | K171448 | 000 |
| 00190837070052 | K171448 | 000 |
| 00190837070045 | K171448 | 000 |
| 00190837070038 | K171448 | 000 |
| 00190837070021 | K171448 | 000 |
| 00190837070014 | K171448 | 000 |
| 00190837070007 | K171448 | 000 |
| 00190837033095 | K171448 | 000 |