Mustang Suture Anchor 916000-5500

GUDID 00811714035604

Mustang Suture Anchor, 5.5mm with two suture tapes

RESPONSIVE ORTHOPEDICS LLC

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: 00811714035604
• NIH Device Record Key: fc5f8e52-7332-4db8-8343-8a82e08639f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mustang Suture Anchor
• Version Model Number: 916000-5500
• Catalog Number: 916000-5500
• Company DUNS: 002745858
• Company Name: RESPONSIVE ORTHOPEDICS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: 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
GS1	00811714035604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222763

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-26
• Device Publish Date: 2022-10-18

On-Brand Devices [Mustang Suture Anchor]

• 00811714035604: Mustang Suture Anchor, 5.5mm with two suture tapes
• 00811714035598: Mustang Suture Anchor, 4.5mm with one suture tape
• 00811714035567: Mustang Suture Anchor, 5.5mm w/ three sutures
• 00811714035543: Mustang Suture Anchor, 4.5mm w/ two sutures