FDA.reportPublic FDA data

NGM WAVE PLIF Cage

Primary DI
04251631420446
Brand
NGM WAVE PLIF Cage
Company
NGMedical GmbH
Model
13 x 28 mm 0°
Catalog number
WE132800
Device description
NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operative outcome to the greatest extent possible. NGM WAVE® PLIF cages are made of PEEK-OPTIMA Natural and tantalum (pins) in accordance with ASTM F560. The implants are available in various heights, lengths and lordosis angles. The cranial and caudal side of the implant is fitted with teeth to achieve a good degree of anchoring of the implant.
Published
2026-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212050000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251631420446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251631420446042516314204464251631420446

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00840606176347LucentSPINAL ELEMENTS, INC.MAX2026-10-22
00840606184847LucentSPINAL ELEMENTS, INC.MAX2026-10-22
00840606197106LucentSPINAL ELEMENTS, INC.MAX2026-10-22
B648C29510000Savant Lumbar Interbody Fusion SystemCURITEVA, INC.MAX2026-10-19
M719GLL11403DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
M719GLL11503DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
M719GLL11603DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
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00810161900398EARP, 14X25X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
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00810161900435EARP, 14X30X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
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00810161900466EARP, 14X35X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900473EARP, 14X35X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900480EARP, 14X35X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900497EARP, 14X35X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900503EARP, 14X40X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900510EARP, 14X40X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900527EARP, 14X40X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900534EARP, 18X30X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900541EARP, 18X30X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900558EARP, 18X30X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900565EARP, 18X30X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
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00810161900596EARP, 18X35X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900602EARP, 18X35X14 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16