ExoShape

GUDID M970110100123002

EXOSHAPE Deployment Cartridge, 12mm x 30mm, Angled, Knurled

Medshape, Inc.

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: M970110100123002
• NIH Device Record Key: 492225bb-ea06-4096-b1ee-be7c5c97088b
• Commercial Distribution Discontinuation: 2023-06-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ExoShape
• Version Model Number: 1101-00-1230
• 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	M970110100123002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111471

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

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]

• M9701101020000: ACL Procedure Pack, Sterile
• M970110000093007: EXOSHAPE Deployment Cartridge, 9mm x 30mm, Angled-Back
• M970110000083006: EXOSHAPE Deployment Cartridge, 8mm x 30mm, Angled-Back
• M970110000073005: EXOSHAPE Deployment Cartridge, 7mm x 30mm, Angled-Back
• M970110000062800: EXOSHAPE Deployment Cartridge, 6mm x 28mm, Angled-Back
• M970110100123002: EXOSHAPE Deployment Cartridge, 12mm x 30mm, Angled, Knurled
• M970110100093008: EXOSHAPE Deployment Cartridge, 9mm x 30mm, Angled, Knurled
• M970110100083007: EXOSHAPE Deployment Cartridge, 8mm x 30mm, Angled, Knurled
• M970110100073006: EXOSHAPE Deployment Cartridge, 7mm x 30mm, Angled, Knurled
• M970110000123001: EXOSHAPE Deployment Cartridge, 12mm x 30mm, Angled-Back