FDA.report

14x16mm, 6° KODIAK CORPECTOMY TRIAL

Primary DI
00819824027489
Brand
14x16mm, 6° KODIAK CORPECTOMY TRIAL
Company
MET 1 TECHNOLOGIES, LLC
Model
07-0014G
Catalog number
07-0014G
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
false

Related Records

Contact Domains

Product Codes

CodeName
HWTTemplate

Product Code Classifications

CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Premarket Submissions

SubmissionSupplement
K222806000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00819824027489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00819824027489008198240274898198240274890819824027489

GMDN Terms

TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

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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0081982402893610x22x6° KODIAK PLIF TRIAL04-2210P604-2210P62023-09-29
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0081982402895012x22x6° KODIAK PLIF TRIAL04-2212P604-2212P62023-09-29
0081982402896713x22x6° KODIAK PLIF TRIAL04-2213P604-2213P62023-09-29
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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
0081982402908715x26x6° KODIAK PLIF TRIAL04-2615P604-2615P62023-09-29
0081982402909416x26x6° KODIAK PLIF TRIAL04-2616P604-2616P62023-09-29

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