| Primary Device ID | 00819824028974 |
| NIH Device Record Key | 73da7ef7-1662-4859-b638-433719de852b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 14x22x6° KODIAK PLIF TRIAL |
| Version Model Number | 04-2214P6 |
| Catalog Number | 04-2214P6 |
| Company DUNS | 080474650 |
| Company Name | MET 1 TECHNOLOGIES, LLC |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| 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 | 9154726762 |
| yone@met1tech.com | |
| Phone | 9154726762 |
| yone@met1tech.com | |
| Phone | 9154726762 |
| yone@met1tech.com | |
| Phone | 9154726762 |
| yone@met1tech.com | |
| Phone | 9154726762 |
| yone@met1tech.com | |
| Phone | 9154726762 |
| yone@met1tech.com | |
| Phone | 9154726762 |
| yone@met1tech.com | |
| Phone | 9154726762 |
| yone@met1tech.com | |
| Phone | 9154726762 |
| yone@met1tech.com | |
| Phone | 9154726762 |
| yone@met1tech.com | |
| Phone | 9154726762 |
| yone@met1tech.com | |
| Phone | 9154726762 |
| yone@met1tech.com | |
| Phone | 9154726762 |
| yone@met1tech.com | |
| Phone | 9154726762 |
| yone@met1tech.com | |
| Phone | 9154726762 |
| yone@met1tech.com | |
| Phone | 9154726762 |
| yone@met1tech.com | |
| Phone | 9154726762 |
| yone@met1tech.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00819824028974 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00819824028974]
Moist Heat or Steam Sterilization
[00819824028974]
Moist Heat or Steam Sterilization
[00819824028974]
Moist Heat or Steam Sterilization
[00819824028974]
Moist Heat or Steam Sterilization
[00819824028974]
Moist Heat or Steam Sterilization
[00819824028974]
Moist Heat or Steam Sterilization
[00819824028974]
Moist Heat or Steam Sterilization
[00819824028974]
Moist Heat or Steam Sterilization
[00819824028974]
Moist Heat or Steam Sterilization
[00819824028974]
Moist Heat or Steam Sterilization
[00819824028974]
Moist Heat or Steam Sterilization
[00819824028974]
Moist Heat or Steam Sterilization
[00819824028974]
Moist Heat or Steam Sterilization
[00819824028974]
Moist Heat or Steam Sterilization
[00819824028974]
Moist Heat or Steam Sterilization
[00819824028974]
Moist Heat or Steam Sterilization
[00819824028974]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-09 |
| Device Publish Date | 2023-09-29 |
| 00819824028905 - 07x22x6° KODIAK PLIF TRIAL | 2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve |
| 00819824028912 - 08x22x6° KODIAK PLIF TRIAL | 2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve |
| 00819824028929 - 09x22x6° KODIAK PLIF TRIAL | 2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve |
| 00819824028936 - 10x22x6° KODIAK PLIF TRIAL | 2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve |
| 00819824028943 - 11x22x6° KODIAK PLIF TRIAL | 2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve |
| 00819824028950 - 12x22x6° KODIAK PLIF TRIAL | 2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve |
| 00819824028967 - 13x22x6° KODIAK PLIF TRIAL | 2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve |
| 00819824028974 - 14x22x6° KODIAK PLIF TRIAL | 2023-10-09The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The Kodiak Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transformational (TLIF) approach. The implants have a central endplate window to permit packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces, and lateral windows for radiographic visualization. The implants are additively manufactured from Ti-6Al-4V ELI and are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy. |
| 00819824028974 - 14x22x6° KODIAK PLIF TRIAL | 2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve |