FDA.reportPublic FDA data

LnK Spinal Instrument System

Primary DI
08800108665048
Brand
LnK Spinal Instrument System
Company
L&K BIOMED CO. ,LTD.
Model
CS02-0101
Catalog number
CS02-0101
Device description
PROBE STRAIGHT
Published
2024-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08800108665048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800108665048088001086650488800108665048

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic surgical probeA slender, rod-like, hand-held manual surgical instrument intended to be inserted through an endoscope (e.g., arthroscope, laparoscope) to explore, measure, and/or perform therapeutic procedures during various types of surgical interventions (excludes cryosurgery). It is made of metallic and/or synthetic polymer material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
631159324
Device count
1
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809986492791CastleLoc-P Anterior Cervical Plate System6610-4020S2026-06-09
08809986492807CastleLoc-P Anterior Cervical Plate System6610-4021S2026-06-09
08809986492814CastleLoc-P Anterior Cervical Plate System6610-4022S2026-06-09
08809986479938CastleLoc Pectus Bar SystemPB28-31602026-06-08
08809986479945CastleLoc Pectus Bar SystemPB28-21602026-06-08
08809986491404CastleLoc-P Anterior Cervical Plate System6913-17602026-06-08
08809986491411CastleLoc-P Anterior Cervical Plate System6913-17632026-06-08
08809986491428CastleLoc-P Anterior Cervical Plate System6913-17662026-06-08
08809986491435CastleLoc-P Anterior Cervical Plate System6913-17692026-06-08
08809986491442CastleLoc-P Anterior Cervical Plate System6913-17722026-06-08
08809986491459CastleLoc-P Anterior Cervical Plate System6914-17652026-06-08
08809986491466CastleLoc-P Anterior Cervical Plate System6914-17692026-06-08
08809986491473CastleLoc-P Anterior Cervical Plate System6914-17732026-06-08
08809986491480CastleLoc-P Anterior Cervical Plate System6914-17772026-06-08
08809986491497CastleLoc-P Anterior Cervical Plate System6914-17812026-06-08
08809986491503CastleLoc-P Anterior Cervical Plate System6914-17852026-06-08
08809986491510CastleLoc-P Anterior Cervical Plate System6914-17892026-06-08
08809986491527CastleLoc-P Anterior Cervical Plate System6914-17932026-06-08
08809986491534CastleLoc-P Anterior Cervical Plate System6914-17972026-06-08
08809986491541CastleLoc-P Anterior Cervical Plate System6609-35122026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376544519InvictusALPHATEC SPINE, INC.LXH2026-07-30
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00193082167430ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167447ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167454ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167461ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167478ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167492ANTERIS Thoracolumbar Plate SystemSPINECRAFT, LLCLXH2026-07-30
00193082167508ANTERIS Thoracolumbar Plate SystemSPINECRAFT, LLCLXH2026-07-30
00199150081905Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-30
00810166521703X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
00810166523004X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
00810166523011X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
00850041805863X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
04251631412526BEE PLIF CageNGMedical GmbHLXH2026-07-30
07899258632346Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258634647Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653242Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653259Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653266Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653280Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653297Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
09421028110853Tensioner, AP SizerENZTEC LIMITEDLXH2026-07-30
09421028110877Tensioner, BalancerENZTEC LIMITEDLXH2026-07-30
09421028110884Tensioner, DistractorENZTEC LIMITEDLXH2026-07-30
00198506093487ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29
00198506093500ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29
00198506093524ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29
00198506093548ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29