The following data is part of a premarket notification filed by Newclip Technics with the FDA for Activ Ankle.
| Device ID | K173641 |
| 510k Number | K173641 |
| Device Name: | Activ Ankle |
| Classification | Plate, Fixation, Bone |
| Applicant | Newclip Technics PA De La Lande Saint Martin - 45 Rue Des Garottieres Haute-goulaine, FR 44 115 |
| Contact | Gaelle Lussori |
| Correspondent | J. D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-24 |
| Decision Date | 2018-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700569671990 | K173641 | 000 |
| 03700569626136 | K173641 | 000 |
| 03700569626129 | K173641 | 000 |
| 03700569626112 | K173641 | 000 |
| 03700569626105 | K173641 | 000 |
| 03700569626099 | K173641 | 000 |
| 03700569626075 | K173641 | 000 |
| 03700569626068 | K173641 | 000 |
| 03700569626044 | K173641 | 000 |
| 03700569626037 | K173641 | 000 |
| 03700569626020 | K173641 | 000 |
| 03700569626013 | K173641 | 000 |
| 03700569625993 | K173641 | 000 |
| 03700569625986 | K173641 | 000 |
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| 03700569626143 | K173641 | 000 |
| 03700569626150 | K173641 | 000 |
| 03700569626174 | K173641 | 000 |
| 03700569671983 | K173641 | 000 |
| 03700569671976 | K173641 | 000 |
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| 03700569657956 | K173641 | 000 |
| 03700569657949 | K173641 | 000 |
| 03700569657932 | K173641 | 000 |
| 03700569657925 | K173641 | 000 |
| 03700569657918 | K173641 | 000 |
| 03700569657901 | K173641 | 000 |
| 03700569657895 | K173641 | 000 |
| 03700569657888 | K173641 | 000 |
| 03700569654818 | K173641 | 000 |
| 03700569654771 | K173641 | 000 |
| 03700569625962 | K173641 | 000 |