OMEGA 3910-500-471

GUDID 37613327464819

Omega 4.75mm PEEK Knotless Anchor System, Single

STRYKER CORPORATION

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: 37613327464819
• NIH Device Record Key: eea4a087-0296-4710-a9a3-6e8a6a3cab12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMEGA
• Version Model Number: 3910500471
• Catalog Number: 3910-500-471
• Company DUNS: 187502109
• Company Name: STRYKER CORPORATION
• 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

Customer Support Contacts

• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327464818 [Primary]
GS1	37613327464819 [Package]; Contains: 07613327464818; Package: pack [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181083

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: 2
• Public Version Date: 2019-03-21
• Device Publish Date: 2019-01-02

On-Brand Devices [OMEGA]

• 37613327464833: Omega 4.75mm PEEK Knotless Anchor System, Double-Double
• 37613327464826: Omega 6.5mm PEEK Knotless Anchor and Eyelet, Single
• 37613327464819: Omega 4.75mm PEEK Knotless Anchor System, Single
• 37613327464802: Omega 3.9mm PEEK Knotless Anchor System, Double-Double
• 37613327464796: Omega 3.9mm PEEK Knotless Anchor System, Single
• 07613327412284: 3.9MM OMEGA AWL
• 07613327412277: 4.75MM OMEGA DRILL
• 07613327412260: 4.75MM OMEGA AWL
• 07613327412253: 3.9MM OMEGA TAP
• 07613327412246: 3.9MM OMEGA DRILL
• 07613327412239: 4.75MM OMEGA TAP
• 37613327514149: Omega 6.5mm PEEK Knotless Anchor System, Single
• 07613327550115: 3.9MM OMEGA TAP
• 07613327550078: 3.9MM OMEGA DRILL
• 07613327550061: 4.75MM OMEGA TAP