Fix2Lock

GUDID 08800071018254

Biocomposite Lateral Anchor '4.8*22.8' 1Line(Metabiomed)(USP#2)(White/Green)

OSTEONIC CO.,Ltd.

Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 08800071018254
• NIH Device Record Key: 5fc7ae4f-0183-45fa-b62a-84b467f4c404
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fix2Lock
• Version Model Number: BLA-4722-1030
• Company DUNS: 688999370
• Company Name: OSTEONIC CO.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800071018254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202806

FDA Product Code

• MAI: Fastener, Fixation, Biodegradable, Soft Tissue

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-13
• Device Publish Date: 2021-07-05

On-Brand Devices [Fix2Lock]

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