Multi-drive Interference Screw
- Primary DI
- 00810135962155
- Brand
- Multi-drive Interference Screw
- Company
- NVision Biomedical Technologies, Inc.
- Model
- INTF-40-10P
- Device description
- 4.0mm Dia X 10mm 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
- Published
- 2025-05-07
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K200428 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00810135962155 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00810135962155 | 00810135962155 | 810135962155 | 0810135962155 |
GMDN Terms#
| Term | Definition |
|---|---|
| Tendon/ligament bone anchor, non-bioabsorbable | A non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)]. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Length | 0 | |
| Outer Diameter | 0 |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts#
| Phone | |
|---|---|
| 210-545-3713 | Diana@Nvisionbiomed.com |
Regulatory Flags#
- DUNS number
- 047486041
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- true
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