| Primary Device ID | 00840916129187 |
| NIH Device Record Key | 3d2f8dd9-083f-46f3-ab34-6e9730cc15ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Optimus |
| Version Model Number | 130203 |
| Company DUNS | 004022104 |
| Company Name | SPINAL ELEMENTS |
| 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 | true |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840916129187 [Primary] |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840916129187]
Moist Heat or Steam Sterilization
[00840916129187]
Moist Heat or Steam Sterilization
[00840916129187]
Moist Heat or Steam Sterilization
[00840916129187]
Moist Heat or Steam Sterilization
[00840916129187]
Moist Heat or Steam Sterilization
[00840916129187]
Moist Heat or Steam Sterilization
[00840916129187]
Moist Heat or Steam Sterilization
[00840916129187]
Moist Heat or Steam Sterilization
[00840916129187]
Moist Heat or Steam Sterilization
[00840916129187]
Moist Heat or Steam Sterilization
[00840916129187]
Moist Heat or Steam Sterilization
[00840916129187]
Moist Heat or Steam Sterilization
[00840916129187]
Moist Heat or Steam Sterilization
[00840916129187]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-12-03 |
| Device Publish Date | 2017-07-05 |
| 00840916129323 | Optimus PEEK End Cap 29 x 36, 7deg - B |
| 00840916129316 | Optimus PEEK End Cap 29 x 36, 5deg - B |
| 00840916129309 | Optimus PEEK End Cap 29 x 36, 3deg - B |
| 00840916129293 | Optimus PEEK End Cap 29 x 36, 7deg - A |
| 00840916129286 | Optimus PEEK End Cap 29 x 36, 5deg - A |
| 00840916129279 | Optimus PEEK End Cap 29 x 36, 3deg - A |
| 00840916129262 | Optimus PEEK End Cap 25 x 32, 7deg - B |
| 00840916129255 | Optimus PEEK End Cap 25 x 32, 5deg - B |
| 00840916129248 | Optimus PEEK End Cap 25 x 32, 3deg - B |
| 00840916129231 | Optimus PEEK End Cap 25 x 32, 7deg - A |
| 00840916129224 | Optimus PEEK End Cap 25 x 32, 5deg - A |
| 00840916129217 | Optimus PEEK End Cap 25 x 32, 3deg - A |
| 00840916129354 | Optimus Screw 32mm |
| 00840916129347 | Optimus Screw 28mm |
| 00840916129330 | Optimus Screw 24mm |
| 00840916129200 | Optimus Anterior Lumbar Plate 29 x 36, 13mm |
| 00840916129194 | Optimus Anterior Lumbar Plate 29 x 36, 12mm |
| 00840916129187 | Optimus Anterior Lumbar Plate 29 x 36, 11mm |
| 00840916129170 | Optimus Anterior Lumbar Plate 29 x 36, 10mm |
| 00840916129163 | Optimus Anterior Lumbar Plate 29 x 36, 9mm |
| 00840916129156 | Optimus Anterior Lumbar Plate 25 x 32, 13mm |
| 00840916129149 | Optimus Anterior Lumbar Plate 25 x 32, 12mm |
| 00840916129132 | Optimus Anterior Lumbar Plate 25 x 32, 11mm |
| 00840916129125 | Optimus Anterior Lumbar Plate 25 x 32, 10mm |
| 00840916129118 | Optimus Anterior Lumbar Plate 25 x 32, 9mm |
| 00840916151010 | ASSEMBLED U-JOINT LINKAGE |
| 00840916151003 | FIXED ANGLE LINK DRIVER OUTER |
| 00840916148096 | FIXED ANGLE LINK DRIVER |