INTEGRATE-C R1314L07

GUDID G2308H1CR034L70

Rasping Trial - Large footprint 7deg, 13/14 height

Happe Spine, LLC

Internal spinal fixation procedure kit, reusable

• Primary Device ID: G2308H1CR034L70
• NIH Device Record Key: a0a4ea01-e199-46b5-8336-906b2e67bb3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTEGRATE-C
• Version Model Number: Rasping Trial - Large 20 x 15 x 13/14mm , 7 deg
• Catalog Number: R1314L07
• Company DUNS: 118446952
• Company Name: Happe Spine, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 616-984-0204
• Email: xxxx@xx.xx
• Phone: 616-984-0204
• Email: xxxx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G2308H1CR034L70 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222004

FDA Product Code

• LYQ: Accessories, Fixation, Spinal Intervertebral Body

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[G2308H1CR034L70]

Moist Heat or Steam Sterilization

[G2308H1CR034L70]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-04
• Device Publish Date: 2023-08-25

On-Brand Devices [INTEGRATE-C]

• G2308H2AC05S070: HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 5 mm ,7 deg
• G2308H2AC14S070: HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 14 mm ,7 deg
• G2308H2AC13S070: HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 13 mm ,7 deg
• G2308H2AC12S070: HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 12 mm ,7 deg
• G2308H2AC11S070: HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 11 mm ,7 deg
• G2308H2AC10S070: HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 10 mm ,7 deg
• G2308H2AC09S070: HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 9 mm ,7 deg
• G2308H2AC08S070: HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 8 mm ,7 deg
• G2308H2AC07S070: HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 7 mm ,7 deg
• G2308H2AC06S070: HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 6 mm ,7 deg
• G2308H2AC05S100: HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 5 mm , 10 deg
• G2308H2AC14S100: HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 14 mm , 10 deg
• G2308H2AC14M100: HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 14 mm , 10 deg
• G2308H2AC14M070: HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 14 mm ,7 deg
• G2308H2AC13S100: HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 13 mm , 10 deg
• G2308H2AC13M100: HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 13 mm , 10 deg
• G2308H2AC13M070: HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 13 mm ,7 deg
• G2308H2AC12S100: HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 12 mm , 10 deg
• G2308H2AC12M100: HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 12 mm , 10 deg
• G2308H2AC12M070: HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 12 mm ,7 deg
• G2308H2AC11S100: HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 11 mm , 10 deg
• G2308H2AC11M100: HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 11 mm , 10 deg
• G2308H2AC11M070: HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 11 mm ,7 deg
• G2308H2AC10S100: HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 10 mm , 10 deg
• G2308H2AC10M100: HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 10 mm , 10 deg
• G2308H2AC10M070: HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 10 mm ,7 deg
• G2308H2AC09S100: HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 9 mm , 10 deg
• G2308H2AC09M100: HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 9 mm , 10 deg
• G2308H2AC09M070: HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 9 mm ,7 deg
• G2308H2AC08S100: HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 8 mm , 10 deg
• G2308H2AC08M100: HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 8 mm , 10 deg
• G2308H2AC08M070: HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 8 mm ,7 deg
• G2308H2AC07S100: HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 7 mm , 10 deg
• G2308H2AC07M100: HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 7 mm , 10 deg
• G2308H2AC07M070: HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 7 mm ,7 deg
• G2308H2AC06S100: HAPPE Spine - ACDF INTEGRATE-C Small, 15 x 12 x 6 mm , 10 deg
• G2308H2AC06M100: HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 6 mm , 10 deg
• G2308H2AC06M070: HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 6 mm ,7 deg
• G2308H2AC05M100: HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 5 mm , 10 deg
• G2308H2AC05M070: HAPPE Spine - ACDF INTEGRATE-C Medium, 17 x 14 x 5 mm ,7 deg
• G2308H2AC14L100: HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 14 mm , 10 deg
• G2308H2AC14L070: HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 14 mm ,7 deg
• G2308H2AC13L100: HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 13 mm , 10 deg
• G2308H2AC13L070: HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 13 mm ,7 deg
• G2308H2AC12L100: HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 12 mm , 10 deg
• G2308H2AC12L070: HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 12 mm ,7 deg
• G2308H2AC11L100: HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 11 mm , 10 deg
• G2308H2AC11L070: HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 11 mm ,7 deg
• G2308H2AC10L100: HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 10 mm , 10 deg
• G2308H2AC10L070: HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 10 mm ,7 deg