FDA.report

KODIAK CORPECTOMY IMPLANT, 12x14mm, 44mmx0°

Primary DI
00819824025751
Brand
KODIAK CORPECTOMY IMPLANT, 12x14mm, 44mmx0°
Company
MET 1 TECHNOLOGIES, LLC
Model
41442400K
Catalog number
41442400K
Device description
THE MET ONE TECHNOLOGIES KODIAK C SPINAL VERTEBRAL BODY REPLACEMENT DEVICE IS A THORACOLUMBAR VERTEBRAL BODY REPLACEMENT DEVICE THAT IS IMPLANTED TO ACHIEVE ANTERIOR DECOMPRESSION OF THE SPINAL CORD AND NEURAL TISSUES AND TO RESTORE THE HEIGHT OF A COLLAPSED VERTEBRAL BODY. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY.
Published
2023-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MQPSpinal Vertebral Body Replacement Device

Product Code Classifications

CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Premarket Submissions

SubmissionSupplement
K222806000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K222806000Kodiak C Spinal Implant SystemMet One Technologies, LLC2022-12-22ODP

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00819824025751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00819824025751008198240257518198240257510819824025751

GMDN Terms

TermDefinition
Vertebral body prosthesisAn implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.

Device Sizes

TypeValueUnit
Angle0degree
Height44Millimeter
Length12Millimeter
Width14Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
9154726762yone@met1tech.com

Regulatory Flags

DUNS number
080474650
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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0081982402892909x22x6° KODIAK PLIF TRIAL04-2209P604-2209P62023-09-29
0081982402893610x22x6° KODIAK PLIF TRIAL04-2210P604-2210P62023-09-29
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0081982402898115x22x6° KODIAK PLIF TRIAL04-2215P604-2215P62023-09-29
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0081982402902509x26x6° KODIAK PLIF TRIAL04-2609P604-2609P62023-09-29
0081982402903210x26x6° KODIAK PLIF TRIAL04-2610P604-2610P62023-09-29
0081982402904911x26x6° KODIAK PLIF TRIAL04-2611P604-2611P62023-09-29
0081982402905612x26x6° KODIAK PLIF TRIAL04-2612P604-2612P62023-09-29
0081982402906313x26x6° KODIAK PLIF TRIAL04-2613P604-2613P62023-09-29
0081982402907014x26x6° KODIAK PLIF TRIAL04-2614P604-2614P62023-09-29
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0081982402909416x26x6° KODIAK PLIF TRIAL04-2616P604-2616P62023-09-29

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