FDA.reportPublic FDA data

BEE PLIF

Primary DI
04251631415961
Brand
BEE PLIF
Company
NGMedical GmbH
Model
Distractor 15 x 30 mm 0°
Catalog number
I325
Device description
All instruments provided by NGMedical are reusable surgical instruments with the purpose of enabling the implantation of an NGMedical implant. The surgical technique of each implant describes the instruments to be used. The instruments may only be used in direct connection with implants from NGMedical and as described in the respective surgical techniques.
Published
2023-11-07
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211413000
K212050000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211413000BEE PLIF CageNGMedical GmbH2021-08-27MAX
K212050000NGM WAVE PLIF CageNGMedical GmbH2021-12-01MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251631415961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251631415961042516314159614251631415961

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
342615118
Device count
1
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
04251631420200NGM WAVE PLIF Cage10 x 28 mm 0°WE1028002026-07-06
04251631420217NGM WAVE PLIF Cage10 x 28 mm 6°WE1028062026-07-06
04251631420224NGM WAVE PLIF Cage10 x 28 mm 12°WE1028122026-07-06
04251631420231NGM WAVE PLIF Cage10 x 32 mm 6°WE1032062026-07-06
04251631420248NGM WAVE PLIF Cage10 x 32 mm 12°WE1032122026-07-06
04251631420255NGM WAVE PLIF Cage11 x 24 mm 0°WE1124002026-07-06
04251631420262NGM WAVE PLIF Cage11 x 24 mm 6°WE1124062026-07-06
04251631420279NGM WAVE PLIF Cage11 x 24 mm 12°WE1124122026-07-06
04251631420286NGM WAVE PLIF Cage11 x 28 mm 0°WE1128002026-07-06
04251631420293NGM WAVE PLIF Cage11 x 28 mm 6°WE1128062026-07-06
04251631420309NGM WAVE PLIF Cage11 x 28 mm 12°WE1128122026-07-06
04251631420316NGM WAVE PLIF Cage11 x 32 mm 6°WE1132062026-07-06
04251631420323NGM WAVE PLIF Cage11 x 32 mm 12°WE1132122026-07-06
04251631420330NGM WAVE PLIF Cage12 x 24 mm 0°WE1224002026-07-06
04251631420347NGM WAVE PLIF Cage12 x 24 mm 6°WE1224062026-07-06
04251631420354NGM WAVE PLIF Cage12 x 24 mm 12°WE1224122026-07-06
04251631420361NGM WAVE PLIF Cage12 x 28 mm 0°WE1228002026-07-06
04251631420385NGM WAVE PLIF Cage12 x 28 mm 12°WE1228122026-07-06
04251631420392NGM WAVE PLIF Cage12 x 32 mm 6°WE1232062026-07-06
04251631420408NGM WAVE PLIF Cage12 x 32 mm 12°WE1232122026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889795155856APEX 3D Total Ankle Replacement SystemParagon 28, Inc.LXH2026-09-29
00889795155863APEX 3D Total Ankle Replacement SystemParagon 28, Inc.LXH2026-09-29
07899258696058Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-29
07901125621138Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-29
07901125621145Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-29
07901125621312Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-29
07901125621329Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-29
07901125621336Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-29
07901125621350Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-29
07901125621398Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-29
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07630542794995Surgical Manual InstrumentMedacta International SALXH2026-09-28
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07630542795640Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795657Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795718Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795725Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795732Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542795893Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542797262Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542797279Surgical Manual InstrumentMedacta International SALXH2026-09-28
07630542797286Surgical Manual InstrumentMedacta International SALXH2026-09-28
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07630542799754Surgical Manual InstrumentMedacta International SALXH2026-09-28