Fix2Lock

GUDID 08800071006718

Biocomposite Medial Anchor '5.5' 3Line(Teleflex)(Tape USP#5)(White)(USP#2)(White/Black,Blue 1)

OSTEONIC CO.,Ltd.

Tendon/ligament bone anchor, bioabsorbable
Primary Device ID08800071006718
NIH Device Record Keyed9dab70-4206-4fd4-a06a-fcfe29de515b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFix2Lock
Version Model NumberBMA-5519-3430
Company DUNS688999370
Company NameOSTEONIC CO.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800071006718 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAIFastener, Fixation, Biodegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-13
Device Publish Date2021-07-05

On-Brand Devices [Fix2Lock]

08809595978822Biocomposite Lateral Anchor '4.75' 1L (Metabiomed)(USP#2)(W/G)
08809595977597Biocomposite Healmax Medial Anchor '5.25' 2Line(Teleflex)(Tape USP#5)(White/Blue)(USP#2)(White/
08809595977580Biocomposite Healmax Medial Anchor '5.25' 2Line(Teleflex)(Tape USP#5)(White/Blue)(White)
08809595977573Biocomposite Healmax Medial Anchor '5.25' 1Line(Teleflex)(Tape USP#5)(White/Blue)
08809595977320Biocombi Lateral Anchor '4.75' 1Line(Metabiomed)(USP#2)(White/Green)
08809595976996PEEK Healmax Lateral anchor '4.5' 1Line(Teleflex)(USP#2)(White/Blue 1)
08809595976989PEEK Healmax Lateral anchor '4.5' 1Line(Teleflex)(USP#2)(White/Black)
08809595976972PEEK Healmax Lateral anchor '4.5' 1Line(Teleflex)(USP#2)(Blue 1)
08809595976965PEEK Healmax Lateral anchor '4.5' 1Line(Teleflex)(USP#2)(White)
08809595976958PEEK Healmax Lateral anchor '5.5' 1Line(Teleflex)(USP#2)(White/Blue 1)
08809595976941PEEK Healmax Lateral anchor '5.5' 1Line(Teleflex)(USP#2)(White/Black)
08809595976934PEEK Healmax Lateral anchor '5.5' 1Line(Teleflex)(USP#2)(Blue 1)
08809595976927PEEK Healmax Lateral anchor '5.5' 1Line(Teleflex)(USP#2)(White)
08809595976910PEEK Lateral Lateral anchor '5.5' 1Line(Teleflex)(USP#2)(White/Blue 1)
08809595976903PEEK Lateral Lateral anchor '5.5' 1Line(Teleflex)(USP#2)(White/Black)
08809595976897PEEK Lateral Lateral anchor '5.5' 1Line(Teleflex)(USP#2)(Blue 1)
08809595976880PEEK Lateral anchor '5.5' 1Line(Teleflex)(USP#2)(White)
08809595976835PEEK Lateral Lateral anchor '4.5' 1Line(Teleflex)(USP#2)(White/Blue 1)
08809595976828PEEK Lateral Lateral anchor '4.5' 1Line(Teleflex)(USP#2)(White/Black)
08809595976811PEEK Lateral Lateral anchor '4.5' 1Line(Teleflex)(USP#2)(Blue 1)
08809595976804PEEK Lateral anchor '4.5' 1Line(Teleflex)(USP#2)(White)
08809595976774PEEK Healmax Lateral anchor '5.5' 1Line(Metabiomed)(USP#2)(White/Green)
08809595976675PEEK Healmax Lateral anchor '4.5' 1Line(Metabiomed)(USP#2)(White/Green)
08809595976590Biocomposite Healmax Medial Anchor '5.25' 3Line(Teleflex)(USP#2)(Blue 1, White/Blue 1, White/Bl
08809595976583Biocomposite Healmax Medial Anchor '5.25' 3Line(Teleflex)(USP#2)(White, Blue 1, White/Blue 1)
08809595976576Biocomposite Healmax Medial Anchor '5.25' 3Line(Teleflex)(USP#2)(White, Blue 1, White/Black)
08809595976552Biocomposite Healmax Medial Anchor '5.25' 2Line(Teleflex)(USP#2)(White/Blue 1, White/Black)
08809595976545Biocomposite Healmax Medial Anchor '5.25' 2Line(Teleflex)(USP#2)(White/Blue 1, Blue 1)
08809595976538Biocomposite Healmax Medial Anchor '5.25' 2Line(Teleflex)(USP#2)(White/Black, Blue 1)
08809595976521Biocomposite Healmax Medial Anchor '5.25' 2Line(Teleflex)(USP#2)(White, Blue 1)
08809595976507Biocomposite Healmax Medial Anchor '5.25' 2Line(Teleflex)(USP#2)(White, White/Black)
08809595976491Biocomposite Healmax Medial Anchor '4.75' 3Line(Teleflex)(USP#2)(Blue 1, White/Blue 1, White/Bl
08809595976484Biocomposite Healmax Medial Anchor '4.75' 3Line(Teleflex)(USP#2)(White, Blue 1, White/Blue 1)
08809595976477Biocomposite Healmax Medial Anchor '4.75' 3Line(Teleflex)(USP#2)(White, Blue 1, White/Black)
08809595976460Biocomposite Healmax Medial Anchor '4.75' 3Line(Teleflex)(USP#2)(White, White/blue 1, White/Bla
08809595976453Biocomposite Healmax Medial Anchor '4.75' 2Line(Teleflex)(USP#2)(White/Blue 1, White/Black)
08809595976446Biocomposite Healmax Medial Anchor '4.75' 2Line(Teleflex)(USP#2)(White/Blue 1, Blue 1)
08809595976439Biocomposite Healmax Medial Anchor '4.75' 2Line(Teleflex)(USP#2)(White/Black, Blue 1)
08809595976422Biocomposite Healmax Medial Anchor '4.75' 2Line(Teleflex)(USP#2)(White, Blue 1)
08809595976408Biocomposite Healmax Medial Anchor '4.75' 2Line(USP#2)(White,White/Black)
08809595976392PEEK Lateral anchor '5.5' 1Line(Metabiomed)(USP#2)(White/Green)
08809595976385PEEK Lateral anchor '4.5' 1Line(Metabiomed)(USP#2)(White/Green)
08809595976378Biocomposite Healmax Medial Anchor '5.25' 3Line(Teleflex)(USP#2)(White, White/blue 1, White/Bla
08809595976361Biocomposite Healmax Medial Anchor '5.25' 2Line(Teleflex)(USP#2)(White, White/Blue 1)
08809595976354Biocomposite Healmax Medial Anchor '4.75' 2Line(Teleflex)(USP#2)(White, White/Blue 1)
08809595975999Biocomposite Lateral Anchor '4.75' 1Line(Teleflex)(USP#2)(White/Blue 1)
08809595975982Biocomposite Lateral Anchor '4.75' 1Line(Teleflex)(USP#2)(White/Black)
08809595975975Biocomposite Lateral Anchor '4.75' 1Line(Teleflex)(USP#2)(Blue 1)
08809595975968Biocomposite Lateral Anchor '4.75' 1Line(Teleflex)(USP#2)(White)
08809595975951Biocomposite Medial Anchor '5.5' 3Line(Teleflex)(USP#2)(Blue 1, White/Blue 1, White/Black)
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