ExoShape Femoral

GUDID M97016000001001

ExoShape Femoral, 10MM x 21MM

Medshape, Inc.

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: M97016000001001
• NIH Device Record Key: 46f739b5-8a8b-4ef8-a97e-7c974f6b45bb
• Commercial Distribution Discontinuation: 2023-06-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ExoShape Femoral
• Version Model Number: 1600-00-010
• 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	M97016000001001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132783

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 Femoral]

• M97016000001102: ExoShape Femoral, 11MM x 21MM
• M97016000001001: ExoShape Femoral, 10MM x 21MM
• M97016000000909: ExoShape Femoral, 9MM x 21MM
• M97016000000808: ExoShape Femoral, 8MM x 21MM