FDA.report

510(k) K232755

Device
Arthrex FiberTape and TigerTape Cerclage Sutures
Applicant
Arthrex, Inc.
510(k) number
K232755
Product code
HTN
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-06
Date received
2023-09-08
Regulation
888.3030
Classification name
Washer, Bolt Nut
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Ruth Segall
Address
1370 Creekside Blvd. Naples FL US 34108 34108

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company2024-02-02
K232780CC-Clip® Implant SystemCc-Instruments, Inc.2023-12-18
K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.2022-08-22
K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.2022-06-06
K220650TriMed Ripcord DeviceTriMed, Inc.2022-06-01