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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 the device name listed in this FDA 510(k) record. The listed applicant is T.A.G. Medical Products Corporation, Ltd.. It received FDA 510(k) clearance on 2019-05-19 under 510(k) 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. The listed applicant is T.A.G. Medical Products Corporation, Ltd.. The 510(k) number is K190125.

When did FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire receive FDA 510(k) clearance?

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 510(k) number K190125.

Who is the listed applicant 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 510(k) record lists T.A.G. Medical Products Corporation, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07557836Comparative Clinical Study of Implant Stability and Peri-implant Bone Loss in Two Implant DesignsCOMPLETEDNCT07544706A Follow-Up Study of Straight and Tapered Dental Implants in the Front Upper JawACTIVE_NOT_RECRUITING

Other records listing T.A.G. Medical Products Corporation, Ltd. as applicant

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Related Devices (Code: MBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

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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