FDA.reportPublic FDA data

INTEGRATE-C

Primary DI
G2308H1TD002040
Brand
INTEGRATE-C
Company
Happe Spine, LLC
Model
INTEGRATE™-C SINGLE END TRIAL CASE BASE
Catalog number
TD00204
Device description
INTEGRATE™-C Single End Trial Instrument Case Base
Published
2024-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G2308H1TD002040PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
616-984-0204xxxx@xx.xx

Regulatory Flags#

DUNS number
118446952
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G2308H1CH000320INTEGRATE-CInserter Handle DSH000000322026-10-21
G2308H1TD002010INTEGRATE-CINTEGRATE™-C CASE BASETD002012024-04-10
G2308H1TD002020INTEGRATE-CINTEGRATE™ LID TD002022024-04-10
G2308H1FT05L100INTEGRATE-CTrial-Large 20x15x5mm 10degT05L102024-02-19
G2308H1FT05M100INTEGRATE-CTrial-Medium 17x14x5mm 10degT05M102024-02-19
G2308H1FT05S100INTEGRATE-CTrial-Small 15x12x5mm 10degT05S102024-02-19
G2308H1FT06L070INTEGRATE-CTrial-Large 20x15x6mm 7degT06L072024-02-19
G2308H1FT06L100INTEGRATE-CTrial-Large 20x15x6mm 10degT06L102024-02-19
G2308H1FT06M100INTEGRATE-CTrial-Medium 17x14x6mm 10degT06M102024-02-19
G2308H1FT06S100INTEGRATE-CTrial-Small 15x12x6mm 10degT06S102024-02-19
G2308H1FT07L100INTEGRATE-CTrial-Large 20x15x7mm 10degT07L102024-02-19
G2308H1FT07M100INTEGRATE-CTrial-Medium 17x14x7mm 10degT07M102024-02-19
G2308H1FT07S100INTEGRATE-CTrial-Small 15x12x7mm 10degT07S102024-02-19
G2308H1FT08L100INTEGRATE-CTrial-Large 20x15x8mm 10degT08L102024-02-19
G2308H1FT08M100INTEGRATE-CTrial-Medium 17x14x8mm 10degT08M102024-02-19
G2308H1FT08S100INTEGRATE-CTrial-Small 15x12x8mm 10degT08S102024-02-19
G2308H1FT09L100INTEGRATE-CTrial-Large 20x15x9mm 10degT09L102024-02-19
G2308H1FT09M100INTEGRATE-CTrial-Medium 17x14x9mm 10degT09M102024-02-19
G2308H1FT09S100INTEGRATE-CTrial-Small 15x12x9mm 10degT09S102024-02-19
G2308H1FT10L100INTEGRATE-CTrial-Large 20x15x10mm 10degT10L102024-02-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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