PULLUP PULXL01202

GUDID 03760154007122

The Pullup® adjustable cortical fixation device consists of an adjustable nonabsorbable braided loop and titanium button, preloaded with traction and flip threads, designed to be used for ACL reconstruction. The device is supplied sterile, ready to use.

S.B.M

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 Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 03760154007122
• NIH Device Record Key: a4b03ff2-cf09-4d7c-9f06-49734a1d0012
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PULLUP
• Version Model Number: Adjustable cortical fixation device for cortical t
• Catalog Number: PULXL01202
• Company DUNS: 772462123
• Company Name: S.B.M
• 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	03760154007122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151004

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: 2023-12-28
• Device Publish Date: 2023-12-20

On-Brand Devices [PULLUP]

• 03760154008976: The Pullup® adjustable juxtacortical fixation device consists of an adjustable nonabsorbable br
• 03760154008969: The Pullup® adjustable juxtacortical fixation device consists of an adjustable nonabsorbable br
• 03760154007122: The Pullup® adjustable cortical fixation device consists of an adjustable nonabsorbable braided
• 03760154007115: The Pullup® adjustable cortical fixation device consists of an adjustable nonabsorbable braided
• 03760154006163: PULLUP® Ø 4.5 mm cannulated drill bit, to be used with PULLUP and BT LOOP adjustable fixation
• 03760154006156: PULLUP® Cutting pliers, to be used with PULLUP and BT LOOP adjustable fixation devices for ACL
• 03760154003704: The Reusable suture retriever pin is intended to be used with PULLUP and BT LOOP adjustable fixa
• 03760304680786: Complete instrumentation set composed of reusable surgical instruments intended to be used for a