Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021286087

FEI Number

3021286087

Entity Name

TENSOR SURGICAL, INC.

City/State/Country

Las Vegas, NV, US

Establishment Address

6345 S Pecos Rd Ste 212, Las Vegas, NV 89120, US

Establishment Type(s)

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

Owner / Operator

Tensor Surgical, Inc. (Owner Number: 10083936)

Owner / Operator Contact Address

6345 S Pecos Rd Ste 212, Las Vegas, NV 89120, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-12-31

Official Correspondent

Justin Anderson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tensor Surgical, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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3021574846	3D LOGICS LLC	Hillsboro, OR, US
3030089866	ORTOLOG MEDIKAL SANAYI VE TICARET A.S.	Yenimahalle Ankara, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021286087. Last updated year: 2026. Please use registration number 3021286087 when referencing this establishment in official correspondence.