FDA.reportPublic FDA data

Yellowstone

Primary DI
B5872011010
Brand
Yellowstone
Company
SUMMIT SPINE LLC
Model
1
Catalog number
20-1101
Device description
PLIF-TLIF PEEK Inserter
Published
2018-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B5872011010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8772089272info@summitspineco.com

Regulatory Flags#

DUNS number
079539689
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B5872012010Yellowstone120-12012018-03-28
B5872013010Yellowstone120-13012018-03-28
B587C07184040Yellowstone1C071840-42019-08-02
B587C07184540Yellowstone1C071845-42019-08-02
B587C09184040Yellowstone1C091840-42019-08-02
B587C09184540Yellowstone1C091845-42019-08-02
B587C09185040Yellowstone1C091850-42019-08-02
B587C09185540Yellowstone1C091855-42019-08-02
B587C09186040Yellowstone1C091860-42019-08-02
B587C11184040Yellowstone1C111840-42019-08-02
B587C11184540Yellowstone1C111845-42019-08-02
B587C11185040Yellowstone1C111850-42019-08-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800043913099N/ATDM Co., Ltd.MAX2026-06-10
08800043913105N/ATDM Co., Ltd.MAX2026-06-10
08800043913112N/ATDM Co., Ltd.MAX2026-06-10
08800043913129N/ATDM Co., Ltd.MAX2026-06-10
08800043913136N/ATDM Co., Ltd.MAX2026-06-10
08800043913143N/ATDM Co., Ltd.MAX2026-06-10
08800043913150N/ATDM Co., Ltd.MAX2026-06-10
08800043913167N/ATDM Co., Ltd.MAX2026-06-10
08800043913174N/ATDM Co., Ltd.MAX2026-06-10
08800043913181N/ATDM Co., Ltd.MAX2026-06-10
08800043913198N/ATDM Co., Ltd.MAX2026-06-10
08800043913204N/ATDM Co., Ltd.MAX2026-06-10
08800043913211N/ATDM Co., Ltd.MAX2026-06-10
08800043917288N/ATDM Co., Ltd.MAX2026-06-10
08800043917295N/ATDM Co., Ltd.MAX2026-06-10
08800043917301N/ATDM Co., Ltd.MAX2026-06-10
08800043917318N/ATDM Co., Ltd.MAX2026-06-10
08800043917325N/ATDM Co., Ltd.MAX2026-06-10
08800043917332N/ATDM Co., Ltd.MAX2026-06-10
08800043917349N/ATDM Co., Ltd.MAX2026-06-10
08800043967177N/ATDM Co., Ltd.MAX2026-06-10
08800043967184N/ATDM Co., Ltd.MAX2026-06-10
08800043967191N/ATDM Co., Ltd.MAX2026-06-10
08800043967207N/ATDM Co., Ltd.MAX2026-06-10
08800043967214N/ATDM Co., Ltd.MAX2026-06-10
08800043967221N/ATDM Co., Ltd.MAX2026-06-10
08800043967238N/ATDM Co., Ltd.MAX2026-06-10
08800043967245N/ATDM Co., Ltd.MAX2026-06-10
08800043967252N/ATDM Co., Ltd.MAX2026-06-10
08800043967269N/ATDM Co., Ltd.MAX2026-06-10