FDA.reportPublic FDA data

INTEGRATE-C

Primary DI
G2308H2AF08S100
Brand
INTEGRATE-C
Company
Happe Spine, LLC
Model
Small, 15 x 12 x 8 mm , 10 deg
Catalog number
08S10
Device description
HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 8 mm , 10 deg
Published
2023-08-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

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
G2308H2AF08S100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
118446952
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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

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