INNESIS PEEK TL CAGE

GUDID 08809228124336

PEEK Cage, L32 x W12 x H8mm, 4°

BK MEDITECH CO.,LTD.

Polymeric spinal interbody fusion cage

• Primary Device ID: 08809228124336
• NIH Device Record Key: 8f26f539-e27c-4dd7-910e-7d6c97e93c65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNESIS PEEK TL CAGE
• Version Model Number: 46408
• 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	08809228124336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140577

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[08809228124336]

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 TL CAGE]

• 08809228124404: PEEK Cage, L32 x W12 x H15mm, 4°
• 08809228124398: PEEK Cage, L32 x W12 x H14mm, 4°
• 08809228124381: PEEK Cage, L32 x W12 x H13mm, 4°
• 08809228124374: PEEK Cage, L32 x W12 x H12mm, 4°
• 08809228124367: PEEK Cage, L32 x W12 x H11mm, 4°
• 08809228124350: PEEK Cage, L32 x W12 x H10mm, 4°
• 08809228124343: PEEK Cage, L32 x W12 x H9mm, 4°
• 08809228124336: PEEK Cage, L32 x W12 x H8mm, 4°
• 08809228124329: PEEK Cage, L32 x W12 x H7mm, 4°
• 08809228124312: PEEK Cage, L28 x W10 x H15mm, 4°
• 08809228124305: PEEK Cage, L28 x W10 x H14mm, 4°
• 08809228124299: PEEK Cage, L28 x W10 x H13mm, 4°
• 08809228124282: PEEK Cage, L28 x W10 x H12mm, 4°
• 08809228124275: PEEK Cage, L28 x W10 x H11mm, 4°
• 08809228124268: PEEK Cage, L28 x W10 x H10mm, 4°
• 08809228124251: PEEK Cage, L28 x W10 x H9mm, 4°
• 08809228124244: PEEK Cage, L28 x W10 x H8mm, 4°
• 08809228124237: PEEK Cage, L28 x W10 x H7mm, 4°
• 08809228124220: PEEK Cage, L32 x W12 x H15mm, 0°
• 08809228124213: PEEK Cage, L32 x W12 x H14mm, 0°
• 08809228124206: PEEK Cage, L32 x W12 x H13mm, 0°
• 08809228124190: PEEK Cage, L32 x W12 x H12mm, 0°
• 08809228124183: PEEK Cage, L32 x W12 x H11mm, 0°
• 08809228124176: PEEK Cage, L32 x W12 x H10mm, 0°
• 08809228124169: PEEK Cage, L32 x W12 x H9mm, 0°
• 08809228124152: PEEK Cage, L32 x W12 x H8mm, 0°
• 08809228124145: PEEK Cage, L32 x W12 x H7mm, 0°
• 08809228124138: PEEK Cage, L28 x W10 x H15mm, 0°
• 08809228124121: PEEK Cage, L28 x W10 x H14mm, 0°
• 08809228124114: PEEK Cage, L28 x W10 x H13mm, 0°
• 08809228124107: PEEK Cage, L28 x W10 x H12mm, 0°
• 08809228124091: PEEK Cage, L28 x W10 x H11mm, 0°
• 08809228124084: PEEK Cage, L28 x W10 x H10mm, 0°
• 08809228124077: PEEK Cage, L28 x W10 x H9mm, 0°
• 08809228124060: PEEK Cage, L28 x W10 x H8mm, 0°
• 08809228124053: PEEK Cage, L28 x W10 x H7mm, 0°
• 08809763509896: Root Retractor(Small)
• 08809763509889: Root Retractor(Large)
• 08809763509858: Ball Curette(Right)
• 08809763509841: Ball Curette(Left)
• 08809763509483: Trial(D4W12L32H14)
• 08809763509476: Trial(D4W12L32H13)
• 08809763509469: Trial(D4W12L32H12)
• 08809763509452: Trial(D4W12L32H11)
• 08809763509445: Trial(D4W12L32H10)
• 08809763509438: Trial(D4W12L32H9)
• 08809763509421: Trial(D4W12L32H8)
• 08809763509414: Trial(D4W12L32H7)
• 08809763509308: Trial(D4W10L28H14)
• 08809763509292: Trial(D4W10L28H13)