INNESIS PEEK CAGE

GUDID 08809228120727

PEEK Cage, L23 x W11 x H9mm, 0°

BK MEDITECH CO.,LTD.

Polymeric spinal interbody fusion cage
Primary Device ID08809228120727
NIH Device Record Key01222a0c-22ff-4d48-9a4e-d93b0ab1a3e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameINNESIS PEEK CAGE
Version Model Number45109-23
Company DUNS687941818
Company NameBK MEDITECH CO.,LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809228120727 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809228120727]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2015-09-22

On-Brand Devices [INNESIS PEEK CAGE]

08809228120888PEEK Cage, L23 x W11 x H14mm, 8°
08809228120871PEEK Cage, L23 x W11 x H13mm, 8°
08809228120864PEEK Cage, L23 x W11 x H12mm, 8°
08809228120857PEEK Cage, L23 x W11 x H11mm, 8°
08809228120840PEEK Cage, L23 x W11 x H10mmH, 8°
08809228120833PEEK Cage, L23 x W11 x H14mm, 4°
08809228120826PEEK Cage, L23 x W11 x H13mm, 4°
08809228120819PEEK Cage, L23 x W11 x H12mm, 4°
08809228120802PEEK Cage, L23 x W11 x H11mm, 4°
08809228120796PEEK Cage, L23 x W11 x H10mm, 4°
08809228120789PEEK Cage, L23 x W11 x H9mm, 4°
08809228120772PEEK Cage, L23 x W11 x H14mm, 0°
08809228120765PEEK Cage, L23 x W11 x H13mm, 0°
08809228120758PEEK Cage, L23 x W11 x H12mm, 0°
08809228120741PEEK Cage, L23 x W11 x H11mm, 0°
08809228120734PEEK Cage, L23 x W11 x H10mm, 0°
08809228120727PEEK Cage, L23 x W11 x H9mm, 0°
08809228120710PEEK Cage, L23 x W11 x H8mm, 0°
08809763509872Dura Retractor
08809763509865Root Retractor
08809763506680Shaver 13.0mm
08809763506673Shaver 12.0mm
08809763506666Shaver 11.0mm
08809763506659Shaver 10.0mm
08809763506642Shaver 9.0mm
08809763506635Shaver 8.0mm
08809763506628Shaver 7.0mm
08809763505812SQ-Adapter Handle
08809763504389Cage Impactor
08809763504365Distractor 13.0mm
08809763504358Distractor 12.0mm
08809763504341Distractor 11.0mm
08809763504334Distractor 10.0mm
08809763504327Distractor 9.0mm
08809763504310Distractor 8.0mm
08809763504303Distractor 7.0mm
08809763504297Graft Impactor
08809763504280Final Impactor
08809763504204Cage Support
08809763506871Shaver 14.0mm
08809763506864Shaver 13.0mm
08809763506857Shaver 12.0mm
08809763506840Shaver 11.0mm
08809763506833Shaver 10.0mm
08809763506826Shaver 9.0mm
08809763506819Shaver 8.0mm
08809763506802Shaver 7.0mm
08809763506796Shaver 6.0mm
08809763506789Shaver 14.0mm
08809763506772Shaver 13.0mm
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