FDA.reportPublic FDA data

NGM WAVE PLIF Cage

Primary DI
04251631420156
Brand
NGM WAVE PLIF Cage
Company
NGMedical GmbH
Model
9 x 32 mm 6°
Catalog number
WE093206
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
2026-07-30
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251631420156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251631420156042516314201564251631420156

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
04251631412526BEE PLIF CageBEE PLIF Threaded Rod 3.4 mmI3512026-07-30
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
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
00810166521604X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166521611X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166521765X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166523028X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
04251631420095NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420101NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420118NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420125NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420132NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420149NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420163NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420170NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420187NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420194NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421153BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421177BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421184BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421207BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421214BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421221BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421252BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421269BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421276BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421283BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421306BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421313BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421320BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421337BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421351BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421368BEE PLIF CageNGMedical GmbHMAX2026-07-30