Superhawk 908000-0001

GUDID 00811714035314

Superhawk Suture Anchor

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

• Primary Device ID: 00811714035314
• NIH Device Record Key: 636f6292-bbb1-4889-81c6-47b681e6d9b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Superhawk
• Version Model Number: 908000-0001
• Catalog Number: 908000-0001
• 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	00811714035314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202153

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: 2021-10-25
• Device Publish Date: 2021-10-15

On-Brand Devices [Superhawk]

• 00811714035321: Superhawk Suture Anchor
• 00811714035314: Superhawk Suture Anchor
• 00811714035468: Superhawk Broach 3.75
• 00811714035451: Superhawk Drill 3.75 Cannulated
• 00811714035444: Superhawk Drill 3.75
• 00811714035437: Superhawk Drill Guide Circle
• 00811714035079: Superhawk Broach 4.75
• 00811714034980: Superhawk Drill 4.75
• 00811714034959: Superhawk Guide Wire Short
• 00811714034935: Superhawk Drill Guide Insert
• 00811714034904: Superhawk Drill 4.75 Cannulated
• 00811714035086: Superhawk Instrument Set
• 00811714035819: Superhawk Surgical Drill 3.5mm
• 00811714035840: Superhawk 3.0mm Drill
• 00811714035833: Superhawk Circle Drill Guide
• 00811714035499: Superhawk Guide Wire Short
• 00811714035918: Superhawk Broach 4.75 - Packaged
• 00811714035901: Superhawk Broach 3.75 - Packaged