FDA.reportPublic FDA data

BEE PLIF

Primary DI
04251631412144
Brand
BEE PLIF
Company
NGMedical GmbH
Model
Inline Distractor
Catalog number
I349
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
2026-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
04251631412144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251631412144042516314121444251631412144

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251631416098BEE PLIFInline DistractorI3492023-10-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000880118MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-23
00842528130056OSTEOMEDOSTEOMED LLCLXH2026-10-23
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00888867550407Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550414Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550421Arthrex®ARTHREX, INC.LXH2026-10-23
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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
M739243509000Implant Filling TubeCAPTIVA SPINE, INC.LXH2026-10-23
M739243511000Plunger RodCAPTIVA SPINE, INC.LXH2026-10-23
M739243512000Cannulated Drill, 7mmCAPTIVA SPINE, INC.LXH2026-10-23
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M7399830151077mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
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M7399830151099mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511010mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511111mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511212mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739983101200Coupling - Square ConnectCAPTIVA SPINE, INC.LXH2026-10-23
M739983240300Impaction T-HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739985202530Marking PinCAPTIVA SPINE, INC.LXH2026-10-23
M739985203530Marking PinCAPTIVA SPINE, INC.LXH2026-10-23