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FDA 510(k)

FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire

K-Number: K190125 · 2019-05-19

ApplicantT.A.G. Medical Products Corporation, Ltd.
Decision Date2019-05-19
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire is a medical device manufactured by T.A.G. Medical Products Corporation, Ltd.. It received FDA 510(k) clearance on 2019-05-19 under approval number K190125. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire?

FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire is a medical device that received FDA 510(k) clearance on 2019-05-19. It is manufactured by T.A.G. Medical Products Corporation, Ltd.. The 510(k) number is K190125.

When was FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire approved by the FDA?

FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire received FDA 510(k) clearance on 2019-05-19, under approval number K190125.

What company makes FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire?

FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire is manufactured by T.A.G. Medical Products Corporation, Ltd..

What is the FDA product code for FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire?

The FDA product code for FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire is MBI.

Related Clinical Trials

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Related PubMed Literature

PMID: 39081796 Recent Advances in the Design and Application of Shoulder Arthroplasty Implant Systems and Their Impact on Clinical Outcomes: A Comprehensive Review. Orthopedic research and reviews (2024) PMID: 32224627 Three-Dimensional Printing: A Catalyst for a Changing Orthopaedic Landscape. JBJS reviews (2020) PMID: 31564141 The effect of implant modification: the low contact stress experience. The bone & joint journal (2019)

Other Devices by T.A.G. Medical Products Corporation, Ltd.

K202178VersaLoop Anchor System K210498Betta Link Knotless Implant System K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire K231400Bladeless Trocar – Artemis Lap Cannula K230058Bladeless Trocar – Artemis Lap Cannula

Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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