FDA.reportPublic FDA data

INTEGRATE-C

Primary DI
G2308H1CM000450
Brand
INTEGRATE-C
Company
Happe Spine, LLC
Model
Mallet
Catalog number
M0000045
Device description
Mallet
Published
2023-08-24
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
HXLMallet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXLMalletGeneral, Plastic Surgery1

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
G2308H1CM000450PrimaryHIBCC0

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
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
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
00817493028257Hive Standalone Cervical SystemNanohive Medical LLCHXL2026-05-08
00840311245635Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HXL2026-03-18
00810158218871PRINCETONPrinceton Medical Group, Inc.HXL2026-02-16
B382SD9145561170Surgical DirectSurgical Direct, Inc.HXL2026-02-16
B382SD9141061010Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD9145561160Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD914556300Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD9145970180Surgical DirectSurgical Direct, Inc.HXL2026-02-09
03662663083683ActivLHighridge Medical, LLCHXL2026-02-03
00840180545829General InstrumentsALPHATEC SPINE, INC.HXL2026-01-29
00810158218482PRINCETONPrinceton Medical Group, Inc.HXL2026-01-15
00841731135322Redemption VILEX LLCHXL2026-01-12
03662663154543SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCHXL2025-12-29
03662663154581SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCHXL2025-12-29
03662663155601Zyston Interbody Spacer SystemHighridge Medical, LLCHXL2025-12-29
00840194418157PediflexORTHOPEDIATRICS CORP.HXL2025-12-11
03662663217002Telluride MIS Spinal Fixation SystemHighridge Medical, LLCHXL2025-11-17
03662663267199Timberline Lateral Fusion SystemHighridge Medical, LLCHXL2025-11-16
00887868294976TM Ardis Interbody SystemHighridge Medical, LLCHXL2025-11-14
03662663129831Disc Preparation InstrumentsHighridge Medical, LLCHXL2025-11-14
03662663109239Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCHXL2025-11-12
03662663109703Mergence-A Preparation InstrumentationHighridge Medical, LLCHXL2025-11-12
00810074308748250mm MalletOsteocentric Technologies, Inc.HXL2025-10-21
00810135963657ImpactNVision Biomedical Technologies, Inc.HXL2025-09-24
00810189110526MALLETOsteocentric Technologies, Inc.HXL2025-09-22
B382SD914554370Surgical DirectSurgical Direct, Inc.HXL2025-09-12
B382SD91455610310Surgical DirectSurgical Direct, Inc.HXL2025-09-12
00840314269812gSourceGSOURCE LLCHXL2025-08-29
00850078230041Disruptive MedTechMAHE MEDICAL USA LLCHXL2025-08-14
00757770423750Bausch + LombBausch & Lomb IncorporatedHXL2025-08-08