Apollo

GUDID 10818614020560

VALERIS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 10818614020560
• NIH Device Record Key: f3b8c49a-7c0d-47f3-a477-a4b917aa3fdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apollo
• Version Model Number: XTS-6515
• Company DUNS: 079444554
• Company Name: VALERIS MEDICAL 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818614020563 [Primary]
GS1	10818614020560 [Package]; Contains: 00818614020563; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142230

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: 5
• Public Version Date: 2019-03-21
• Device Publish Date: 2017-08-17

On-Brand Devices [Apollo]

• 10818614021390: 31-15520S
• 00818614021386: 31-14520S
• 10818614021345: 30-16515
• 10818614021338: 30-15515
• 10818614021321: 30-14515
• 10818614021314: 31-16520-TI
• 10818614021307: 31-15520-TI
• 00818614021294: 31-14520-TI
• 10818614021246: XTS-5515-TI
• 10818614020829: 31-14520
• 10818614020812: 31-15520
• 10818614020805: 31-16520
• 10818614020676: LA-6520-TI
• 10818614020669: LA-5520-TI
• 10818614020652: LA-4520-TI
• 10818614020591: MSA-6515-TI
• 10818614020584: MSA-5515-TI
• 10818614020577: MSA-4515-TI
• 10818614020560: XTS-6515
• 10818614020553: XTS-5515
• 10818614020164: LA-6520
• 10818614020157: LA-5520
• 10818614020140: LA-4520
• 10818614020133: MSA-6515
• 10818614020126: MSA-5515
• 10818614020119: MSA-4515
• B048XTS65150: Apollo XT Suture Anchor Delivery System, PEEK Screw, 6.5 x 15mm, Three #2 ForceBraid™ Sutures
• B048XTS55151: Apollo XT Suture Anchor Delivery System, PEEK Screw, 5.5 x 15mm, Three #2 ForceBraid™ Sutures
• B048ST32130: Apollo Labral Suture Anchor Delivery System, PEEK Anchor, 3.2 x 13mm, One #2 ForceBraid™ Sutur
• B048ST25130: Apollo Labral Suture Anchor Delivery System, PEEK Anchor, 2.5 x 13mm, One #2 ForceBraid™ Sutur
• B048MSA6515TI0: Apollo Medial Suture Anchor Delivery System, Titanium Screw, 6.5 x 15mm, Two #2 ForceBraid™ Su
• B048MSA65150: Apollo Medial Suture Anchor Delivery System, PEEK Screw, 6.5 x 15mm, Two #2 ForceBraid™ Suture
• B048MSA5515TI0: Apollo Medial Suture Anchor Delivery System, Titanium Screw, 5.5 x 15mm, Two #2 ForceBraid™ Su
• B048MSA55150: Apollo Medial Suture Anchor Delivery System, PEEK Screw, 5.5 x 15mm, Two #2 ForceBraid™ Suture
• B048MSA4515TI0: Apollo Medial Suture Anchor Delivery System, Titanium Screw, 4.5 x 15mm, Two #2 ForceBraid™ Su
• B048MSA45150: Apollo Medial Suture Anchor Delivery System, PEEK Screw, 4.5 x 15mm, Two #2 ForceBraid™ Suture
• B048LA6520TI0: Apollo Lateral Suture Anchor Delivery System, PEEK Screw, Titanium Punch, 6.5 x 20mm
• B048LA65200: Apollo Lateral Suture Anchor Delivery System, PEEK Screw, 6.5 x 20mm
• B048LA5520TI0: Apollo Lateral Suture Anchor Delivery System, PEEK Screw, Titanium Punch, 5.5 x 20mm
• B048LA55200: Apollo Lateral Suture Anchor Delivery System, PEEK Screw, 5.5 x 20mm
• B048LA4520TI0: Apollo Lateral Suture Anchor Delivery System, PEEK Screw, Titanium Punch, 4.5 x 20mm
• B048LA45200: Apollo Lateral Suture Anchor Delivery System, PEEK Screw, 4.5 x 20mm
• 00818614021621: Apollo Reusable Surgical Tap, 6.5mm
• 00818614021614: Apollo Reusable Surgical Tap, 5.5mm
• 00818614021607: Apollo Reusable Surgical Tap, 4.5mm
• 00818614021591: Apollo Reusable Surgical Punch, 6.5mm
• 00818614021584: Apollo Reusable Surgical Punch, 5.5mm
• 00818614021577: Apollo Reusable Surgical Punch, 4.5mm
• 10818614021376: apollo Medial with Needles, 6.5mm
• 10818614021369: apollo Medial with Needles, 5.5mm