TalarLift STS

Screw, Fixation, Bone

Fusion Orthopedics, LLC

The following data is part of a premarket notification filed by Fusion Orthopedics, Llc with the FDA for Talarlift Sts.

Pre-market Notification Details

• Device ID: K170624
• 510k Number: K170624
• Device Name: TalarLift STS
• Classification: Screw, Fixation, Bone
• Applicant: Fusion Orthopedics, LLC 4135 S. Power Rd., Suite 110 Mesa, AZ 85212
• Contact: Adam Cundiff
• Correspondent: J.d. Webb; The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-03-02
• Decision Date: 2017-08-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840124505100	K170624	000
00819034022724	K170624	000
00819034027408	K170624	000
00819034027415	K170624	000
00819034027422	K170624	000
00819034021611	K170624	000
00819034022021	K170624	000
00819034022151	K170624	000
00819034022168	K170624	000
00819034022175	K170624	000
00819034022182	K170624	000
00819034022199	K170624	000
00819034022205	K170624	000
00819034022212	K170624	000
00819034022229	K170624	000
00819034022243	K170624	000
00819034022717	K170624	000
00819034022700	K170624	000
00819034022540	K170624	000
00819034022557	K170624	000
00819034022564	K170624	000
00819034022571	K170624	000
00819034022588	K170624	000
00819034022595	K170624	000
00819034022601	K170624	000
00819034022618	K170624	000
00819034022625	K170624	000
00819034022632	K170624	000
00819034022649	K170624	000
00819034022656	K170624	000
00819034022663	K170624	000
00819034022687	K170624	000
00819034022694	K170624	000
00819034022250	K170624	000
00819034022267	K170624	000
00819034022441	K170624	000
00819034022458	K170624	000
00819034022465	K170624	000
00819034022472	K170624	000
00819034022489	K170624	000
00819034022496	K170624	000
00819034022502	K170624	000
00819034022519	K170624	000
00819034022526	K170624	000
00819034022533	K170624	000
00819034027347	K170624	000
00819034027354	K170624	000
00819034027361	K170624	000
00819034027378	K170624	000
00819034027385	K170624	000
00819034022434	K170624	000
00819034022427	K170624	000
00819034022274	K170624	000
00819034022281	K170624	000
00819034022298	K170624	000
00819034022304	K170624	000
00819034022311	K170624	000
00819034022328	K170624	000
00819034022335	K170624	000
00819034022342	K170624	000
00819034022359	K170624	000
00819034022366	K170624	000
00819034022373	K170624	000
00819034022380	K170624	000
00819034022397	K170624	000
00819034022403	K170624	000
00819034022410	K170624	000
00819034027392	K170624	000