FDA.reportPublic FDA data

INTEGRATE-C

Primary DI
G2308H1CT034L100
Brand
INTEGRATE-C
Company
Happe Spine, LLC
Model
Trial - Large 20 x 15 x 13/14mm , 10 deg
Catalog number
T034L1
Device description
Trial - large footprint 10deg, 13/14 height
Published
2023-08-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYQAccessories, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYQAccessories, Fixation, Spinal Intervertebral BodyOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222004000INTEGRATE -C Interbody Fusion SystemHappe Spine2023-04-28ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G2308H1CT034L100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Internal spinal fixation procedure kit, reusableA collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are 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
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G2308H1TD002010INTEGRATE-CINTEGRATE™-C CASE BASETD002012024-04-10
G2308H1TD002020INTEGRATE-CINTEGRATE™ LID TD002022024-04-10
G2308H1TD002040INTEGRATE-CINTEGRATE™-C SINGLE END TRIAL CASE BASE TD002042024-04-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493426709neoWave Lumbar, StraightXENIX MEDICAL LLCLYQ2026-04-29
00859373004029PasserEMPIRICAL SPINE, INC.LYQ2026-03-27
00859373004036HolderEMPIRICAL SPINE, INC.LYQ2026-03-27
00859373004043Symbol PlateEMPIRICAL SPINE, INC.LYQ2026-03-27
00859373004050DriverEMPIRICAL SPINE, INC.LYQ2026-03-27
00859373004067Tensioner ClipEMPIRICAL SPINE, INC.LYQ2026-03-27
00859373004074TensionerEMPIRICAL SPINE, INC.LYQ2026-03-27
00840493416441LUX Expandable Interbody SystemXENIX MEDICAL LLCLYQ2026-02-23
00840493416458LUX Expandable Interbody SystemXENIX MEDICAL LLCLYQ2026-02-23
00840493413952RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-12-02
00818345029590RIVA Pedicle Screw SystemXENIX MEDICAL LLCLYQ2025-10-27
00818345029606RIVA Pedicle Screw SystemXENIX MEDICAL LLCLYQ2025-10-27
00818345029620RIVA Pedicle Screw SystemXENIX MEDICAL LLCLYQ2025-10-27
00818345029637RIVA Pedicle Screw SystemXENIX MEDICAL LLCLYQ2025-10-27
00818345029644RIVA Pedicle Screw SystemXENIX MEDICAL LLCLYQ2025-10-27
G616G1090912DS1PTSPt. Solutions, LLCLYQ2025-10-06
G616G1090914DS1PTSPt. Solutions, LLCLYQ2025-10-06
G616G1090916DS1PTSPt. Solutions, LLCLYQ2025-10-06
G616G190912DS0PTSPt. Solutions, LLCLYQ2025-10-06
G616G190914DS0PTSPt. Solutions, LLCLYQ2025-10-06
G616G190916DS0PTSPt. Solutions, LLCLYQ2025-10-06
00818345029583RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00818345029613RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00818345029934RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00818345029958RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00840493413747RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00840493413808RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00840493415413RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
G616S1090912DS1PTSPt. Solutions, LLCLYQ2025-03-10
G616S1090914DS1PTSPt. Solutions, LLCLYQ2025-03-10