Morphix

GUDID M97010000412506

MORPHIX Foot & Ankle 2.5mm x 7mm Anchor with one suture, double armed with needles

Medshape, Inc.

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: M97010000412506
• NIH Device Record Key: 2e326226-0925-48d5-9524-35d9ab7080cd
• Commercial Distribution Discontinuation: 2023-06-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Morphix
• Version Model Number: 1000-04-125
• Company DUNS: 601306413
• Company Name: Medshape, Inc.
• 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: false
• Expiration Date: true
• 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
HIBCC	M97010000412506 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092914

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2023-06-26
• Device Publish Date: 2015-09-22

On-Brand Devices [Morphix]

• M97010001004504: MORPHIX 4.5mm Single Use Drill and Guide Procedure Pack, Sterile
• M9701000100450: MORPHIX 4.5mm Single Use Drill and Guide Procedure Pack, Sterile
• M97010001003503: MORPHIX 3.5mm Single Use Drill and Guide Procedure Pack, Sterile
• M9701000100350: MORPHIX 3.5mm Single Use Drill and Guide Procedure Pack, Sterile
• M97010001002502: MORPHIX 2.5mm Single Use Drill and Guide Procedure Pack, Sterile
• M9701000100250: MORPHIX 2.5mm Single Use Drill and Guide Procedure Pack, Sterile
• M97010000425506: MORPHIX Foot & Ankle 5.5mm x 11mm Anchor with two sutures, each double armed with needles
• M97010000424509: MORPHIX Foot & Ankle 4.5mm x 9mm Anchor with two sutures, each double armed with needles
• M9701000042350: MORPHIX Foot & Ankle 3.5mm x 8mm Anchor with two sutures, each double armed with needles
• M97010000412506: MORPHIX Foot & Ankle 2.5mm x 7mm Anchor with one suture, double armed with needles
• M97010000335500: MORPHIX 5.5mm x 11mm Anchor with three sutures
• M97010000334509: MORPHIX 4.5mm x 9mm Anchor with three sutures
• M97010000333508: MORPHIX 3.5mm x 8mm Anchor with three sutures
• M97010000325509: MORPHIX 5.5mm x 11mm Anchor with two sutures
• M97010000324508: MORPHIX 4.5mm x 9mm Anchor with two sutures
• M97010000323507: MORPHIX 3.5mm x 8mm Anchor with two sutures
• M97010000322506: MORPHIX 2.5mm x 7mm Anchor with two sutures