Multi-drive Interference Screw

GUDID 00810135962162

4.0mm Dia X 15mm Long PEEK Interference Screw. The Multi-Drive Interference Screw System is intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue and tendon transfers in surgeries of the shoulder, elbow, knee, foot/ankle, and hand /wrist. Specifically: Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus Transfer for Achilles Tendon Reconstruction, and Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Reconstruction Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs. Ligament Reconstruction and Tendon Interposition

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00810135962162
NIH Device Record Keye78f2cca-4980-4f62-a245-16b4efa69f85
Commercial Distribution StatusIn Commercial Distribution
Brand NameMulti-drive Interference Screw
Version Model NumberINTF-40-15P
Company DUNS047486041
Company NameNVISION BIOMEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone210-545-3713
EmailDiana@Nvisionbiomed.com
Phone210-545-3713
EmailDiana@Nvisionbiomed.com
Phone210-545-3713
EmailDiana@Nvisionbiomed.com
Phone210-545-3713
EmailDiana@Nvisionbiomed.com
Phone210-545-3713
EmailDiana@Nvisionbiomed.com
Phone210-545-3713
EmailDiana@Nvisionbiomed.com
Phone210-545-3713
EmailDiana@Nvisionbiomed.com
Phone210-545-3713
EmailDiana@Nvisionbiomed.com
Phone210-545-3713
EmailDiana@Nvisionbiomed.com
Phone210-545-3713
EmailDiana@Nvisionbiomed.com
Phone210-545-3713
EmailDiana@Nvisionbiomed.com
Phone210-545-3713
EmailDiana@Nvisionbiomed.com
Phone210-545-3713
EmailDiana@Nvisionbiomed.com
Phone210-545-3713
EmailDiana@Nvisionbiomed.com
Phone210-545-3713
EmailDiana@Nvisionbiomed.com
Phone210-545-3713
EmailDiana@Nvisionbiomed.com

Device Dimensions

Outer Diameter4 Millimeter
Length15 Millimeter
Outer Diameter4 Millimeter
Length15 Millimeter
Outer Diameter4 Millimeter
Length15 Millimeter
Outer Diameter4 Millimeter
Length15 Millimeter
Outer Diameter4 Millimeter
Length15 Millimeter
Outer Diameter4 Millimeter
Length15 Millimeter
Outer Diameter4 Millimeter
Length15 Millimeter
Outer Diameter4 Millimeter
Length15 Millimeter
Outer Diameter4 Millimeter
Length15 Millimeter
Outer Diameter4 Millimeter
Length15 Millimeter
Outer Diameter4 Millimeter
Length15 Millimeter
Outer Diameter4 Millimeter
Length15 Millimeter
Outer Diameter4 Millimeter
Length15 Millimeter
Outer Diameter4 Millimeter
Length15 Millimeter
Outer Diameter4 Millimeter
Length15 Millimeter
Outer Diameter4 Millimeter
Length15 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810135962162 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810135962162]

Moist Heat or Steam Sterilization

[00810135962162]

Moist Heat or Steam Sterilization

[00810135962162]

Moist Heat or Steam Sterilization

[00810135962162]

Moist Heat or Steam Sterilization

[00810135962162]

Moist Heat or Steam Sterilization

[00810135962162]

Moist Heat or Steam Sterilization

[00810135962162]

Moist Heat or Steam Sterilization

[00810135962162]

Moist Heat or Steam Sterilization

[00810135962162]

Moist Heat or Steam Sterilization

[00810135962162]

Moist Heat or Steam Sterilization

[00810135962162]

Moist Heat or Steam Sterilization

[00810135962162]

Moist Heat or Steam Sterilization

[00810135962162]

Moist Heat or Steam Sterilization

[00810135962162]

Moist Heat or Steam Sterilization

[00810135962162]

Moist Heat or Steam Sterilization

[00810135962162]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-15
Device Publish Date2025-05-07

On-Brand Devices [Multi-drive Interference Screw]

008101359622096.0mm Dia X 25mm Long PEEK Interference Screw. The Multi-Drive Interference Screw System is in
008101359621936.0mm Dia X 20mm Long PEEK Interference Screw. The Multi-Drive Interference Screw System is in
008101359621865.0mm Dia X 20mm Long PEEK Interference Screw. The Multi-Drive Interference Screw System is in
008101359621795.0mm Dia X 15mm Long PEEK Interference Screw. The Multi-Drive Interference Screw System is in
008101359621624.0mm Dia X 15mm Long PEEK Interference Screw. The Multi-Drive Interference Screw System is in
008101359621554.0mm Dia X 10mm Long PEEK Interference Screw. The Multi-Drive Interference Screw System is in
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