FDA.reportPublic FDA data

CEMSTOP INSTRUMENTATION

Primary DI
03760177040304
Brand
CEMSTOP INSTRUMENTATION
Company
TEKNIMED
Model
Trial plug DIAMETER 18 mm
Catalog number
T067707
Published
2020-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
03760177040304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760177040304037601770403043760177040304

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement restrictor sizerA non-sterile, hand-held manual orthopaedic surgical instrument designed to be used to measure the diameter of the medullary canal of a bone (e.g., femur, humerus) in order to select the appropriate size orthopaedic cement restrictor implant. It may be in the form of a trial prosthesis attached to an inserter, or a rod with a measuring gauge at the distal end. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
764746723
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760177044326Signature -x CementSVP/N191-14-40002026-01-23
03760177044333Signature -x CementLVP/N191-14-40012026-01-23
03760177044340Signature -x CementMVMVP/N191-14-40022026-01-23
03760177040090GENTAFIX1T040140G2025-09-02
03760177040137GENTAFIX3T040340G2025-09-02
03760177043176GENTAFIX3 MVT040341G2025-09-02
03760177040724CEMENTEK LVT8150LVT8150LV2015-10-16
03760177041080SINPLUS S800580052015-10-16
03760177041677KYPHON ACTIVOS 10C10AC10A2015-10-16
03760177042032MectaBone-P LV03,03,00303,03,0032015-10-16
03760177042384SPINE-FIX USUS040320SUS040320S2015-10-16
03760177042872ODONCER1000-2000µm 5ccT82102052015-10-16
03760177042889ODONCER1000-2000µm 2ccT82102022015-10-16
03760177042902ODONCER100-1000µm 5ccT82101052015-10-16
03760177042919ODONCER100-1000µm 2ccT82101022015-10-16
03760177043060ZVplastyVCF-1009VCF-10092015-10-16
03760177043923COHESIONCM0300CM03002015-10-16
03760177043930VERTEFIXVBC-100VBC-1002015-10-16
03760177043954VERTEMEND66-VMD-10066-VMD-1002015-10-16
03701505801204DynamoSpinal Cement – MV11-59202026-02-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842078112410Axis BeamsEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078116197AlignXEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078123584KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124178Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124185Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124215Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129609KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129616KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129623KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129753IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129777IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129784IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129791IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
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08806373889653LOSPACorentec Co., LtdLXH2026-10-29
08806373894190LOSPACorentec Co., LtdLXH2026-10-29
10850070500101Core Wire, Removal Tool, ReusableCURVAFIX, INC.LXH2026-10-29
10855068008935Removal Tool Core Wire, DisposableCURVAFIX, INC.LXH2026-10-29
10888857615779K2M General InstrumentsVB Spine LLCLXH2026-10-28
M739193990906Non-Modular Convex TrialCAPTIVA SPINE, INC.LXH2026-10-28
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