FDA.reportPublic FDA data

INNESIS PEEK TL CAGE

Primary DI
08809763509308
Brand
INNESIS PEEK TL CAGE
Company
BK MEDITECH CO.,LTD.
Model
52840-14
Device description
Trial(D4W10L28H14)
Published
2023-06-14
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
08809763509308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809763509308088097635093088809763509308

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
687941818
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809763504518INNESIS PEEK CAGE52719-102023-06-23
08809763504686INNESIS PEEK CAGE52790-102023-06-23
08809763504754INNESIS PEEK TL CAGE52810-102023-06-23
08809763504778INNESIS PEEK TL CAGE529302023-06-23
08809763504785INNESIS PEEK TL CAGE52820-102023-06-23
08809763504792INNESIS PEEK TL CAGE52825-102023-06-23
08809763504808INNESIS PEEK CERVICAL CAGE42620-102023-06-23
08809763504280INNESIS PEEK CAGE527192023-06-14
08809763504297INNESIS PEEK CAGE52740-202023-06-14
08809763504389INNESIS PEEK CAGE527902023-06-14
08809763504396INNESIS PEEK CERVICAL CAGE426102023-06-14
08809763504402INNESIS PEEK CERVICAL CAGE426202023-06-14
08809763504419INNESIS PEEK CERVICAL CAGE426302023-06-14
08809763504457INNESIS PEEK TL CAGE528102023-06-14
08809763504464INNESIS PEEK TL CAGE528202023-06-14
08809763504471INNESIS PEEK TL CAGE528252023-06-14
08809763504488INNESIS PEEK TL CAGE528602023-06-14
08809763504693INNESIS PEEK CERVICAL CAGE42610-202023-06-14
08809763504709INNESIS PEEK CERVICAL CAGE42610-102023-06-14
08809763500534MEGA SPINE SYSTEM51710-102023-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091445ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-05
00199150076161Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-05
00840311263882Streamline OCTXtant Medical Holdings, Inc.LXH2026-06-04
00198506091179ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-03
08698940967426SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03
08698940971454SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03
G4533312BT0PEAK MEDICALPeak Medical Distribution Inc.LXH2026-06-03
07613327648355PANGEAStryker GmbHLXH2026-06-02
07613327648379PANGEAStryker GmbHLXH2026-06-02
00199150077359Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
00199150077366Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
00816127027215InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00816127027246InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00816127027253InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00843511128777Omnia Medical TiBrid™-A/SAOMNIA MEDICAL, LLCLXH2026-06-01
00857915007712ObturatorA.M. SURGICAL, INC.LXH2026-06-01
00857915007729CannulaA.M. SURGICAL, INC.LXH2026-06-01
00857915007736RaspA.M. SURGICAL, INC.LXH2026-06-01
07899258648729Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-06-01
B756007053002000Torque Wrench Adaptor HEX 3.5mmShukla MedicalLXH2026-06-01
10884450587727PowerCURVE®Merit Medical Systems, Inc.LXH2026-05-30
00818720013381SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-05-29
00843575124395Juveno™ Femoral Hip SystemB-ONE ORTHO, CORP.LXH2026-05-29
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07630542726170Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542753787Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542753794Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788833Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788840Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788857Surgical Manual InstrumentMedacta International SALXH2026-05-29