NGM WAVE PLIF Cage

FDA UDI

Class II (US FDA UDI)

by NGMedical GmbH

Identity

Trade Name: NGM WAVE PLIF Cage FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 11 x 24 mm 0° FDA UDI
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. FDA UDI

Identifiers

Catalog Number: WE112400 FDA UDI
Primary DI / UDI-DI: 04251631405597 FDA UDI
510(k) Number: K212050 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Polymeric spinal interbody fusion cage FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Polymeric spinal interbody fusion cage

NGM WAVE PLIF Cage by NGMedical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymeric spinal interbody fusion cage.

L-Box® — Innovasis, Inc. · Class II
CoRoent — Nuvasive, Inc. · Class II
Novel Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
S-LIFT® — SPINEFRONTIER, INC. · Class II
Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
TAURUS PEEK Cage System — Medyssey Co., Ltd. · Class II
Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II

Cleared under the same submission

K212050 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: NGMedical GmbH

Sources (1)

FDA UDI 37fac806-152c-4a70-a871-65d75fe4f23c 37 fields · synced Jun 1, 2026