FDA Registration
Active
🇺🇸 United States
TENSOR SURGICAL, INC.
Reg #: 3021286087
·
FEI: 3021286087
·
Expires 2026
Products
1
Proprietary Names
35
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- TENSOR SURGICAL, INC.
- Registration Number
- 3021286087
- FEI Number
- 3021286087
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6345 S Pecos Rd Ste 212
- City
- Las Vegas
- State
- NV
- ZIP
- 89120
- Country
- US
Owner / Operator
- Firm Name
- Tensor Surgical, Inc.
- Operator Number
- 10083936
- Address
- 6345 S Pecos Rd Ste 212
- City
- Las Vegas
- State
- NV
- Postal Code
- 89120
- Country
- US
- Correspondent
- Justin Anderson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2021-12-31 |
Proprietary Names
TransOs SutureTape Fixation Implant System 5010
VersaTip Suture Passer Tip, 40 degree Right, 5/box
VersaTip Percutaneous Suture Passer Handle, Reusable
VersaTip Hip Suture Passer Tip, 30 degree Retrograde, 5/box
TransOs Tunneler Outer Shaft Hook Tip - Shoulder (component)
TransOs Tunneler Awl Inserter, Individual
TransOs SutureTape Fixation Implant System 5020
TransOs Tunneler Medial Awl w/Microfracture Tip
TransOs Tunneler Nut (component)
VersaTip Suture Passer Tip, 20 degree Right, 5/box
VersaTip Suture Passer Tip, Crescent, 5/box
#2 Implantable HS-Fiber® Suture, 3 strands, 12/Box
VersaTip Percutaneous Suture Passer Tip, Straight, 5/box
#2 Implantable HS-Fiber Suture, 12/Box
TransOs Tunneler Thumb Knob (component)
TransOs Suture Organizers, Reusable, 10/Box
VersaTip Suture Passer Tip, 60 degree Retrograde, 5/box
VersaTip Suture Passer Snare, 5/box
TransOs Suture Fixation Implant and VersaTip System 4021
TransOs Tunneler Shoulder Pro
TransOs Tunneler Handle (component)
TransOs Suture Fixation Implant System 4020
VersaTip Suture Passer Tip, 40 degree Left, 5/box
1.4mm Implantable HS SutureTape, 3 strands, 12/Box
TransOs SutureTape Fixation Implant System 5040
VersaTip Hip Suture Passer Handle, Reusable
TransOs Suture Fixation Implant System 4040
TransOs Tunneler Inner Shaft (component)
TransOs Tunneler Shoulder Pro Instrument Set
VersaTip Hip Suture Passer Tip, 60 degree Retrograde, 5/box
VersaTip Suture Passer Tip, 30 degree Retrograde, 5/box
VersaTip Suture Passer Tip, 20 degree Left, 5/box
VersaTip Suture Passer Handle, Reusable
VersaTip Percutaneous Suture Passer Tip, 30 degree Retrograde, 5/box
Shogun Suture Passer
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility