| Primary Device ID | 18257200059614 |
| NIH Device Record Key | 669fbebf-30c1-40a0-945b-e21d52d99ee4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3 DEGREE |
| Version Model Number | 60-6820 |
| Company DUNS | 927083808 |
| Company Name | ORTHOFIX INC. |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18257200059614 [Primary] |
| KWQ | Appliance, fixation, spinal intervertebral body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
[18257200059614]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-27 |
| Device Publish Date | 2019-03-19 |
| 18257200081509 | 3 DEGREE (60-0002) |
| 18257200059676 | 96MM ACP 3DEG 96MM FOUR LEVEL |
| 18257200059669 | 92MM ACP 3DEG 92MM FOUR LEVEL |
| 18257200059652 | 90MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059645 | 88MM ACP 3DEG 88MM FOUR LEVEL |
| 18257200059638 | 86MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059621 | 84MM ACP 3DEG 84MM FOUR LEVEL |
| 18257200059614 | 82MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059607 | 80MM ACP 3DEG 80MM FOUR LEVEL |
| 18257200059591 | 78MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059584 | 76MM ACP 3DEG 76MM FOUR LEVEL |
| 18257200059577 | 74MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059560 | 70MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059553 | 68MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059546 | 66MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059539 | 64MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059522 | 62MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059515 | 60MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059508 | 58MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059492 | 56MM THREE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059485 | 54MM TWO LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059478 | 52MM TWO LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059461 | 50MM TWO LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059454 | 48MM TWO LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059447 | 46MM TWO LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059430 | 44MM TWO LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059423 | 42MM TWO LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059416 | 40MM TWO LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059409 | 38MM TWO LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059393 | 36MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059386 | 34MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059379 | 32MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059362 | 30MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059355 | 28MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059348 | 26MM ONE LEVEL CERVICAL PLATE ASSEMBLY 3DEG ACPS |
| 18257200059331 | 24MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059324 | 22MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059317 | 20MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059300 | 120MM ACP 3DEG 120MM FOUR LEVEL |
| 18257200059294 | 116MM ACP 3DEG 116MM FOUR LEVEL |
| 18257200059287 | 112MM ACP 3DEG 112MM FOUR LEVEL |
| 18257200059270 | 108MM ACP 3DEG 108MM FOUR LEVEL |
| 18257200059263 | 104MM ACP 3DEG 104MM FOUR LEVEL |
| 18257200059256 | 100MM ACP 3DEG 100MM FOUR LEVEL |
| 18257200059249 | FIXED WASHER, 3DEG ACPS |
| 18257200059232 | TOP LOCKING PLATE ASSEMBLY, 3DEG ACPS |
| 18257200059225 | 4.4MM X 18MM PRIMARY BONE SCREW SELF DRILLING/SELF-TAPPING, 3DEG/RELIANT ACPS |
| 18257200059218 | 4.4MM X 16MM PRIMARY BONE SCREW SELF DRILLING/SELF-TAPPING, 3DEG/RELIANT ACPS |
| 18257200059201 | 4.4MM X 14MM PRIMARY BONE SCREW SELF DRILLING/SELF-TAPPING, 3DEG/RELIANT ACPS |
| 18257200059195 | 4.4MM X 12MM PRIMARY BONE SCREW SELF DRILLING/SELF-TAPPING, 3DEG/RELIANT ACPS |