FDA.reportPublic FDA data

TSI

Primary DI
00851797006450
Brand
TSI
Company
TEDAN SURGICAL INNOVATIONS, L.L.C.
Model
DS-0014
Device description
DISTRACTION SCREW, 14 MM, STERILE, 5/BOX
Published
2017-05-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851797006457PackageGS15In Commercial Distribution
00851797006450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085179700645710851797006457
00851797006450008517970064508517970064500851797006450

GMDN Terms#

Term, Definition table
TermDefinition
Spinal intraoperative positioning/manipulation pin, single-useA nonimplantable rod with an external cylindrical and/or polygonal drive intended to be temporarily introduced, with a dedicated tool (not included), into vertebral bone to: 1) assist with positioning of an implantable device; and/or 2) interface with a surgical instrument (e.g., fixation plate, distractor/retractor) during spinal surgery. It may be threaded; however, as a pin it is designed such that a significant length protrudes from vertebral bone once introduced (i.e., not a positioning screw). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14Millimeter

Regulatory Flags#

DUNS number
791619393
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843059127188LattusLAT-20062026-07-20
00843059127195LattusLAT-20072026-07-20
00843059127201LattusLAT-21202026-07-20
00843059127218LattusLAT-31202026-07-20
00843059127225LattusLAT-40902026-07-20
00843059127232LattusLAT-41002026-07-20
00843059127249LattusLAT-41102026-07-20
00843059127256LattusLAT-41202026-07-20
00843059127263LattusLAT-41302026-07-20
00843059127270LattusLAT-41402026-07-20
00843059127287LattusLAT-41502026-07-20
00843059127294LattusLAT-41602026-07-20
00843059127300LattusLAT-41702026-07-20
00843059127317LattusLAT-41802026-07-20
00843059127331LattusLAT-15632026-07-20
00843059127348LattusLAT-15312026-07-20
00843059127355LattusLAT-15322026-07-20
00843059127379LattusLAT-15042026-07-20
00843059127386LattusLAT-05142026-07-20
00843059127393LattusLAT-15152026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857615779K2M General InstrumentsVB Spine LLCLXH2026-10-28
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M739193996906Non-Modular Lordotic Trial AssemblyCAPTIVA SPINE, INC.LXH2026-10-28
M739243999005SG Implant Driver-SCAPTIVA SPINE, INC.LXH2026-10-28
M739985202229Marking PinCAPTIVA SPINE, INC.LXH2026-10-28
M739985203229Marking PinCAPTIVA SPINE, INC.LXH2026-10-28
00810055525164NON NAVIGATED STYLET-OBTURATOR ASSEMBLYSi-Bone Inc.LXH2026-10-27
00810055525188CANNULATED PROBE IMPACTION CAP ASSEMBLYSi-Bone Inc.LXH2026-10-27
00810055525195CANNULATED PROBE HANDLE ASSEMBLYSi-Bone Inc.LXH2026-10-27
00810055525218GRANITE CANNULATED PROBE SHAFTSi-Bone Inc.LXH2026-10-27
00889024702233OsseoFitZimmer, Inc.LXH2026-10-27
00889024702240OsseoFitZimmer, Inc.LXH2026-10-27
00889024702479OsseoFitZimmer, Inc.LXH2026-10-27
00763000880118MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-23
00842528130056OSTEOMEDOSTEOMED LLCLXH2026-10-23
00888867550391Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550407Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550414Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550421Arthrex®ARTHREX, INC.LXH2026-10-23
04251631412144BEE PLIFNGMedical GmbHLXH2026-10-23
M739153997700Cross Connector DriverCAPTIVA SPINE, INC.LXH2026-10-23
M739153998800Cross Connector Counter TorqueCAPTIVA SPINE, INC.LXH2026-10-23
M739243501000Blade DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243502000Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243503000In-Line HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739243504000Tissue DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243505000Tissue ProtectorCAPTIVA SPINE, INC.LXH2026-10-23
M739243506000Adjustable Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243507000Impaction SleeveCAPTIVA SPINE, INC.LXH2026-10-23
M739243508000Self-Feeding DrillCAPTIVA SPINE, INC.LXH2026-10-23