FDA.reportPublic FDA data

BEE PLIF Cage

Primary DI
04251631412526
Brand
BEE PLIF Cage
Company
NGMedical GmbH
Model
BEE PLIF Threaded Rod 3.4 mm
Catalog number
I351
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
2026-07-30
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

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251631412526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251631412526042516314125264251631412526

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
04251631420095NGM WAVE PLIF Cage9 x 24 mm 0°WE0924002026-07-30
04251631420101NGM WAVE PLIF Cage9 x 24 mm 6°WE0924062026-07-30
04251631420118NGM WAVE PLIF Cage9 x 24 mm 12°WE0924122026-07-30
04251631420125NGM WAVE PLIF Cage9 x 28 mm 0°WE0928002026-07-30
04251631420132NGM WAVE PLIF Cage9 x 28 mm 6°WE0928062026-07-30
04251631420149NGM WAVE PLIF Cage9 x 28 mm 12°WE0928122026-07-30
04251631420156NGM WAVE PLIF Cage9 x 32 mm 6°WE0932062026-07-30
04251631420163NGM WAVE PLIF Cage9 x 32 mm 12°WE0932122026-07-30
04251631420170NGM WAVE PLIF Cage10 x 24 mm 0°WE1024002026-07-30
04251631420187NGM WAVE PLIF Cage10 x 24 mm 6°WE1024062026-07-30
04251631420194NGM WAVE PLIF Cage10 x 24 mm 12°WE1024122026-07-30
04251631421153BEE PLIF Cage7 x 30 x 11 mm 0°BLP073011L002026-07-30
04251631421177BEE PLIF Cage8 x 30 x 11 mm 0°BLP083011L002026-07-30
04251631421184BEE PLIF Cage8 x 30 x 11 mm 4°BLP083011L042026-07-30
04251631421207BEE PLIF Cage9 x 30 x 11 mm 0°BLP093011L002026-07-30
04251631421214BEE PLIF Cage9 x 30 x 11 mm 4°BLP093011L042026-07-30
04251631421221BEE PLIF Cage9 x 30 x 11 mm 8°BLP093011L082026-07-30
04251631421252BEE PLIF Cage10 x 30 x 11 mm 0°BLP103011L002026-07-30
04251631421269BEE PLIF Cage10 x 30 x 11 mm 4°BLP103011L042026-07-30
04251631421276BEE PLIF Cage10 x 30 x 11 mm 8°BLP103011L082026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376544519InvictusALPHATEC SPINE, INC.LXH2026-07-30
00193082164828ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167416ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
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
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
00198506093609ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29