| Primary Device ID | G2308H1FT06S100 |
| NIH Device Record Key | bb1ed377-4801-4bb7-9bd1-99bdd504bb2b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INTEGRATE-C |
| Version Model Number | Trial-Small 15x12x6mm 10deg |
| Catalog Number | T06S10 |
| Company DUNS | 118446952 |
| Company Name | Happe Spine, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Phone | 616-984-0204 |
| xxxx@xx.xx | |
| Phone | 616-984-0204 |
| xxxx@xx.xx | |
| Phone | 616-984-0204 |
| xxxx@xx.xx | |
| Phone | 616-984-0204 |
| xxxx@xx.xx | |
| Phone | 616-984-0204 |
| xxxx@xx.xx | |
| Phone | 616-984-0204 |
| xxxx@xx.xx | |
| Phone | 616-984-0204 |
| xxxx@xx.xx | |
| Phone | 616-984-0204 |
| xxxx@xx.xx | |
| Phone | 616-984-0204 |
| xxxx@xx.xx | |
| Phone | 616-984-0204 |
| xxxx@xx.xx | |
| Phone | 616-984-0204 |
| xxxx@xx.xx | |
| Phone | 616-984-0204 |
| xxxx@xx.xx | |
| Phone | 616-984-0204 |
| xxxx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G2308H1FT06S100 [Primary] |
| LYQ | Accessories, Fixation, Spinal Intervertebral Body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[G2308H1FT06S100]
Moist Heat or Steam Sterilization
[G2308H1FT06S100]
Moist Heat or Steam Sterilization
[G2308H1FT06S100]
Moist Heat or Steam Sterilization
[G2308H1FT06S100]
Moist Heat or Steam Sterilization
[G2308H1FT06S100]
Moist Heat or Steam Sterilization
[G2308H1FT06S100]
Moist Heat or Steam Sterilization
[G2308H1FT06S100]
Moist Heat or Steam Sterilization
[G2308H1FT06S100]
Moist Heat or Steam Sterilization
[G2308H1FT06S100]
Moist Heat or Steam Sterilization
[G2308H1FT06S100]
Moist Heat or Steam Sterilization
[G2308H1FT06S100]
Moist Heat or Steam Sterilization
[G2308H1FT06S100]
Moist Heat or Steam Sterilization
[G2308H1FT06S100]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-27 |
| Device Publish Date | 2024-02-19 |
| 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 |