ExoShape Teno

GUDID M970110001062004

EXOSHAPE-TENO Deployment Cartridge, 6mm x 20mm, Flat-Back

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

• Primary Device ID: M970110001062004
• NIH Device Record Key: f9f852cb-78a0-47dd-ab1d-d4fcd3ee7d3e
• Commercial Distribution Discontinuation: 2023-06-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ExoShape Teno
• Version Model Number: 1100-01-0620
• 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	M970110001062004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101808

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: 2023-06-27
• Device Publish Date: 2015-09-22

On-Brand Devices [ExoShape Teno]

• M970110001082006: EXOSHAPE-TENO Deployment Cartridge, 8mm x 20mm, Flat-Back
• M970110001092007: EXOSHAPE-TENO Deployment Cartridge, 9mm x 20mm, Flat-Back
• M970110001072005: EXOSHAPE-TENO Deployment Cartridge, 7mm x 20mm, Flat-Back
• M970110001062004: EXOSHAPE-TENO Deployment Cartridge, 6mm x 20mm, Flat-Back