FDA.report

Yellowstone

Primary DI
B587TL10186580
Brand
Yellowstone
Company
SUMMIT SPINE LLC
Model
1
Catalog number
TL101865-8
Device description
LLIF Sizing Trial 10mm H x 18mm W x 65mm L x 8 degrees
Published
2018-06-26
Public version status
Update
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
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B587TL10186580PrimaryHIBCC0

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.

Device Sizes

TypeValueUnit
Angle8degree
Height10Millimeter
Length65Millimeter
Width18Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
8772089272info@summitspineco.com

Regulatory Flags

DUNS number
079539689
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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B587C09184540Yellowstone1C091845-42019-08-02
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B587C11185540Yellowstone1C111855-42019-08-10
B587C11186040Yellowstone1C111860-42019-08-10
B587C13184040Yellowstone1C131840-42019-08-10
B587C13184540Yellowstone1C131845-42019-08-10
B587C13185040Yellowstone1C131850-42019-08-10
B587C13185540Yellowstone1C131855-42019-08-10
B587C13186040Yellowstone1C131860-42019-08-10
B587C15184040Yellowstone1C151840-42019-08-10
B587C15184540Yellowstone1C151845-42019-08-10
B587C15185040Yellowstone1C151850-42019-08-10

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