INTEGRATE-C T056L1

GUDID G2308HT0506L100

Trial - large footprint 10deg, 5/6 height

Happe Spine, LLC

Internal spinal fixation procedure kit, reusable
Primary Device IDG2308HT0506L100
NIH Device Record Keye127b9f5-8f7d-4367-95a1-1227c6a78728
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTEGRATE-C
Version Model NumberTrial - Large 20 x 15 x 5/6 mm, 10 deg
Catalog NumberT056L1
Company DUNS118446952
Company NameHappe Spine, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone616-984-0204
Emailxxxx@xx.xx
Phone616-984-0204
Emailxxxx@xx.xx
Phone616-984-0204
Emailxxxx@xx.xx
Phone616-984-0204
Emailxxxx@xx.xx
Phone616-984-0204
Emailxxxx@xx.xx
Phone616-984-0204
Emailxxxx@xx.xx
Phone616-984-0204
Emailxxxx@xx.xx
Phone616-984-0204
Emailxxxx@xx.xx
Phone616-984-0204
Emailxxxx@xx.xx
Phone616-984-0204
Emailxxxx@xx.xx
Phone616-984-0204
Emailxxxx@xx.xx
Phone616-984-0204
Emailxxxx@xx.xx
Phone616-984-0204
Emailxxxx@xx.xx
Phone616-984-0204
Emailxxxx@xx.xx
Phone616-984-0204
Emailxxxx@xx.xx
Phone616-984-0204
Emailxxxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG2308HT0506L100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYQAccessories, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[G2308HT0506L100]

Moist Heat or Steam Sterilization

[G2308HT0506L100]

Moist Heat or Steam Sterilization

[G2308HT0506L100]

Moist Heat or Steam Sterilization

[G2308HT0506L100]

Moist Heat or Steam Sterilization

[G2308HT0506L100]

Moist Heat or Steam Sterilization

[G2308HT0506L100]

Moist Heat or Steam Sterilization

[G2308HT0506L100]

Moist Heat or Steam Sterilization

[G2308HT0506L100]

Moist Heat or Steam Sterilization

[G2308HT0506L100]

Moist Heat or Steam Sterilization

[G2308HT0506L100]

Moist Heat or Steam Sterilization

[G2308HT0506L100]

Moist Heat or Steam Sterilization

[G2308HT0506L100]

Moist Heat or Steam Sterilization

[G2308HT0506L100]

Moist Heat or Steam Sterilization

[G2308HT0506L100]

Moist Heat or Steam Sterilization

[G2308HT0506L100]

Moist Heat or Steam Sterilization

[G2308HT0506L100]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-12-18
Device Publish Date2023-08-24

On-Brand Devices [INTEGRATE-C]

G2308H2AC05S070HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 5 mm ,7 deg
G2308H2AC14S070HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 14 mm ,7 deg
G2308H2AC13S070HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 13 mm ,7 deg
G2308H2AC12S070HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 12 mm ,7 deg
G2308H2AC11S070HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 11 mm ,7 deg
G2308H2AC10S070HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 10 mm ,7 deg
G2308H2AC09S070HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 9 mm ,7 deg
G2308H2AC08S070HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 8 mm ,7 deg
G2308H2AC07S070HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 7 mm ,7 deg
G2308H2AC06S070HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 6 mm ,7 deg
G2308H2AC05S100HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 5 mm , 10 deg
G2308H2AC14S100HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 14 mm , 10 deg
G2308H2AC14M100HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 14 mm , 10 deg
G2308H2AC14M070HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 14 mm ,7 deg
G2308H2AC13S100HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 13 mm , 10 deg
G2308H2AC13M100HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 13 mm , 10 deg
G2308H2AC13M070HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 13 mm ,7 deg
G2308H2AC12S100HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 12 mm , 10 deg
G2308H2AC12M100HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 12 mm , 10 deg
G2308H2AC12M070HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 12 mm ,7 deg
G2308H2AC11S100HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 11 mm , 10 deg
G2308H2AC11M100HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 11 mm , 10 deg
G2308H2AC11M070HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 11 mm ,7 deg
G2308H2AC10S100HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 10 mm , 10 deg
G2308H2AC10M100HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 10 mm , 10 deg
G2308H2AC10M070HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 10 mm ,7 deg
G2308H2AC09S100HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 9 mm , 10 deg
G2308H2AC09M100HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 9 mm , 10 deg
G2308H2AC09M070HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 9 mm ,7 deg
G2308H2AC08S100HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 8 mm , 10 deg
G2308H2AC08M100HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 8 mm , 10 deg
G2308H2AC08M070HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 8 mm ,7 deg
G2308H2AC07S100HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 7 mm , 10 deg
G2308H2AC07M100HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 7 mm , 10 deg
G2308H2AC07M070HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 7 mm ,7 deg
G2308H2AC06S100HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 6 mm , 10 deg
G2308H2AC06M100HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 6 mm , 10 deg
G2308H2AC06M070HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 6 mm ,7 deg
G2308H2AC05M100HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 5 mm , 10 deg
G2308H2AC05M070HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 5 mm ,7 deg
G2308H2AC14L100HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 14 mm , 10 deg
G2308H2AC14L070HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 14 mm ,7 deg
G2308H2AC13L100HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 13 mm , 10 deg
G2308H2AC13L070HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 13 mm ,7 deg
G2308H2AC12L100HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 12 mm , 10 deg
G2308H2AC12L070HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 12 mm ,7 deg
G2308H2AC11L100HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 11 mm , 10 deg
G2308H2AC11L070HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 11 mm ,7 deg
G2308H2AC10L100HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 10 mm , 10 deg
G2308H2AC10L070HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 10 mm ,7 deg
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