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510(k) K170957

Device
ReConnex Pre-Sutured Tendon
Applicant
AlloSource
510(k) number
K170957
Product code
GAT  
Decision
Substantially Equivalent (SESE)
Decision date
2018-03-20
Date received
2017-03-31
Regulation
878.5000
Classification name
Suture, Nonabsorbable, Synthetic, Polyethylene
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Pamela Vetter
Address
6278 S. Troy Cir. Centennial CO US 80111 80111

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GAT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261021EasyWhip FamilyWinter Innovations, Inc.2026-07-01
K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC2026-05-06
K254275HyperSuture All Green Extension LineThreadstone, LLC2026-03-23
K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.2026-02-19
K253145Pre-Sutured TendonRti Surgical, Inc.2025-10-22
K253024ProZip Knotless ImplantRiverpoint Medical2025-10-16
K252225PowerKnot High Strength SuturesMedacta International S.A.2025-09-12
K252201HS FiberRiverpoint Medical2025-08-13
K242201HyperSuture White/Green Extension LineThreadstone, LLC2025-03-27
K241376HyperSuture All Blue Extension LineThreadstone, LLC2024-08-09
K234079HyperSuture Extension LineThreadstone, LLC2024-05-10
K231163HS Fiber SuturesRiverpoint Medical2024-01-05
K230311HyperSutureThreadstone, LLC2023-11-24
K231183Non absorbable Surgical Polyester SutureShandong Haidike Medical Products Co., Ltd.2023-08-25
K223500SuperBall Meniscal Repair SystemArcuro Medical , Ltd.2023-08-10

Legacy Summary#

summary

FDA Review#

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