HEALIX ADVANCE ORTHOCORD 222307

GUDID 10886705021420

HEALIX ADVANCE PEEK 3 SUTURE ANCHOR w/ORTHOCORD PEEK Anchor (1) Violet, (1) Blue Strand, (1) Blue Striped, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm) 5.5mm

Medos International Sàrl

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 10886705021420
• NIH Device Record Key: ccf77ef4-b972-470d-9356-46e8cf7106a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEALIX ADVANCE ORTHOCORD
• Version Model Number: 222307
• Catalog Number: 222307
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705021420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120449

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: 2023-12-22
• Device Publish Date: 2015-09-01

On-Brand Devices [HEALIX ADVANCE ORTHOCORD]

• 20886705021540: HEALIX ADVANCE PEEK MULTIPACK - 3 SUTURE (5) PEEK Anchors, Each Anchor contains (1) Violet (1) B
• 20886705021533: HEALIX ADVANCE PEEK MULTIPACK - 2 SUTURE (5) PEEK Anchors, Each Anchor contains (1) Violet (1) B
• 20886705021526: HEALIX ADVANCE BR MULTIPACK - 3 SUTURE (5) TCP/PLGA Absorbable Anchors, Each Anchor contains (1)
• 20886705021519: HEALIX ADVANCE BR MULTIPACK - 2 SUTURE (5) TCP/PLGA Absorbable Anchors, Each Anchor contains (1)
• 20886705021502: HEALIX ADVANCE PEEK MULTIPACK - 3 SUTURE (5) PEEK Anchors, Each Anchor contains (1) Violet (1) B
• 20886705021496: HEALIX ADVANCE PEEK MULTIPACK - 2 SUTURE (5) PEEK Anchors, Each Anchor contains (1) Violet (1) B
• 20886705021489: HEALIX ADVANCE BR MULTIPACK - 3 SUTURE (5) TCP/PLGA Absorbable Anchors, Each Anchor contains (1)
• 20886705021472: HEALIX ADVANCE BR MULTIPACK - 2 SUTURE (5) TCP/PLGA Absorbable Anchors, Each Anchor contains (1)
• 10886705021468: HEALIX ADVANCE PEEK ANCHOR w/ORTHOCORD AND NEEDLES PEEK Anchor (1) Violet (1) Blue strand, Size
• 10886705021451: HEALIX ADVANCE PEEK 3 SUTURE ANCHOR w/ORTHOCORD PEEK Anchor (1) Violet, (1) Blue Strand, (1) Blu
• 10886705021444: HEALIX ADVANCE PEEK ANCHOR w/ORTHOCORD PEEK Anchor (1) Violet (1) Blue strand, Size 2 (5 metric)
• 10886705021437: HEALIX ADVANCE PEEK ANCHOR w/ORTHOCORD AND NEEDLES PEEK Anchor (1) Violet (1) Blue strand, Size
• 10886705021420: HEALIX ADVANCE PEEK 3 SUTURE ANCHOR w/ORTHOCORD PEEK Anchor (1) Violet, (1) Blue Strand, (1) Blu
• 10886705021413: HEALIX ADVANCE PEEK ANCHOR w/ORTHOCORD PEEK Anchor (1) Violet (1) Blue strand, Size 2 (5 metric)
• 10886705021406: HEALIX ADVANCE PEEK 3 SUTURE ANCHOR w/ORTHOCORD PEEK Anchor (1) Violet, (1) Blue Strand, (1) Blu
• 10886705021390: HEALIX ADVANCE PEEK ANCHOR w/ORTHOCORD PEEK Anchor (1) Violet (1) Blue strand, Size 2 (5 metric)
• 10886705021383: HEALIX ADVANCE BR ANCHOR w/ORTHOCORD AND NEEDLES TCP/PLGA Absorbable Anchor (1) Violet (1) Blue
• 10886705021376: HEALIX ADVANCE BR 3 SUTURE ANCHOR w/ORTHOCORD TCP/PLGA Absorbable Anchor (1) Violet (1) Blue Str
• 10886705021369: HEALIX ADVANCE BR ANCHOR w/ORTHOCORD TCP/PLGA Absorbable Anchor (1) Violet (1) Blue Strand, Size
• 10886705021352: HEALIX ADVANCE BR ANCHOR w/ORTHOCORD AND NEEDLES TCP/PLGA Absorbable Anchor (1) Violet (1) Blue
• 10886705021345: HEALIX ADVANCE BR 3 SUTURE ANCHOR w/ORTHOCORD TCP/PLGA Absorbable Anchor (1) Violet (1) Blue Str
• 10886705021338: HEALIX ADVANCE BR ANCHOR w/ORTHOCORD TCP/PLGA Absorbable Anchor (1) Violet (1) Blue Strand, Size
• 10886705021321: HEALIX ADVANCE BR 3 SUTURE ANCHOR w/ORTHOCORD TCP/PLGA Absorbable Anchor (1) Violet (1) Blue Str
• 10886705021314: HEALIX ADVANCE BR ANCHOR w/ORTHOCORD TCP/PLGA Absorbable Anchor (1) Violet (1) Blue Strand, Size