INNESIS PEEK CERVICAL CAGE

GUDID 08809228122417

Cervical PEEK Cage, L12 x W14 x H5mm

BK MEDITECH CO.,LTD.

Polymeric spinal interbody fusion cage

• Primary Device ID: 08809228122417
• NIH Device Record Key: 88ebe2ed-8dd5-4503-a62e-527b72bb3afb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNESIS PEEK CERVICAL CAGE
• Version Model Number: 42205
• Company DUNS: 687941818
• Company Name: BK MEDITECH CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809228122417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132483

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[08809228122417]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-22

On-Brand Devices [INNESIS PEEK CERVICAL CAGE]

• 08809228122523: Cervical PEEK Cage, L14 x W16 x H10mm
• 08809228122516: Cervical PEEK Cage, L14 x W16 x H9mm
• 08809228122509: Cervical PEEK Cage, L14 x W16 x H8mm
• 08809228122493: Cervical PEEK Cage, L14 x W16 x H7mm
• 08809228122486: Cervical PEEK Cage, L14 x W16 x H6mm
• 08809228122479: Cervical PEEK Cage, L14 x W16 x H5mm
• 08809228122462: Cervical PEEK Cage, L12 x W14 x H10mm
• 08809228122455: Cervical PEEK Cage, L12 x W14 x H9mm
• 08809228122448: Cervical PEEK Cage, L12 x W14 x H8mm
• 08809228122431: Cervical PEEK Cage, L12 x W14 x H7mm
• 08809228122424: Cervical PEEK Cage, L12 x W14 x H6mm
• 08809228122417: Cervical PEEK Cage, L12 x W14 x H5mm
• 08809763508141: Trial(W1614H10)
• 08809763508134: Trial(W16L14H9)
• 08809763508127: Trial(W16L14H8)
• 08809763508110: Trial(W16L14H7)
• 08809763508103: Trial(W16L14H6)
• 08809763508097: Trial(W16L14H5)
• 08809763508080: Trial(W14L12H10)
• 08809763508073: Trial(W14L12H9)
• 08809763508066: Trial(W14L12H8)
• 08809763508059: Trial(W14L12H7)
• 08809763508042: Trial(W14L12H6)
• 08809763508035: Trial(W14L12H5)
• 08809763504709: Inserter
• 08809763504693: Inserter
• 08809763504440: Distraction Screw Driver
• 08809763504433: Distractor
• 08809763504426: Graft Case
• 08809763504419: Graft Impactor
• 08809763504402: Graft Impactor
• 08809763504396: Inserter
• 08809763503894: Distraction Screw
• 08809763505836: SQ-Adapter Mini I-type Handle
• 08809763504808: Graft Impactor
• 08809763504761: Graft Case
• 08809763504747: Distraction Screw
• 08809763504730: Distraction Screw
• 08809763504723: Distraction Screw
• 08809763504716: Distraction Screw