NGM WAVE PLIF Cage WE132812

GUDID 04251631405962

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.

NGMedical GmbH

Polymeric spinal interbody fusion cage

• Primary Device ID: 04251631405962
• NIH Device Record Key: 35f88885-acee-409f-9f30-90629d1a5de0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NGM WAVE PLIF Cage
• Version Model Number: 13 x 28 mm 12°
• Catalog Number: WE132812
• Company DUNS: 342615118
• Company Name: NGMedical GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251631405962 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212050

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-22
• Device Publish Date: 2022-07-14

On-Brand Devices [NGM WAVE PLIF Cage]

• 04251631405573: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631406198: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631406181: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631406174: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631406167: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631406150: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631406143: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631406136: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631406129: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631406112: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631406105: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631406099: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631406082: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631406075: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631406068: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631406051: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631406044: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631406037: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631406020: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631406013: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631406006: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405993: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405986: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405979: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405962: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405955: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405948: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405931: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405924: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405917: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405900: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405894: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405887: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405870: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405863: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405856: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405849: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405832: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405825: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405818: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405801: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405795: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405788: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405771: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405764: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405757: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405740: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405733: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405726: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat
• 04251631405719: NGM WAVE® PLIF cages have been specially adapted to suit the local anatomy to ensure the operat