| Primary Device ID | 00840916159580 |
| NIH Device Record Key | 0ec33a43-7bd6-4874-98bf-2211ae58e953 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zeus-T |
| Version Model Number | LM-10002 |
| Company DUNS | 004022104 |
| Company Name | SPINAL ELEMENTS |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840916159580 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
[00840916159580]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2020-04-28 |
| 00840916158743 | CURVED TLIF INSERTER |
| 00840916159948 | TLIF INSERTER |
| 00840916159900 | TLIF INSERTER INNER SHAFT WITH SLAP HAMMER ADAPTER |
| 00840916159863 | WELD TEDAN RETRACTOR JOINTS |
| 00840916159849 | 36 MM MIS TLIF -BULLETNOSE TRIALS |
| 00840916159825 | NON-INSULATED LATERAL DILATORS |
| 00840916159771 | ZEUS-T EXTENDED INSERTER |
| 00840916159764 | ZEUS-T INSERTER |
| 00840916159627 | ZEUS-T TAMP, CURVED |
| 00840916159610 | ZEUS-P STRAIGHT SIZER, 15MM |
| 00840916159603 | ZEUS-P STRAIGHT SIZER, 13MM |
| 00840916159597 | ZEUS-P STRAIGHT SIZER, 11MM |
| 00840916159580 | ZEUS-P STRAIGHT SIZER, 9MM |
| 00840916159573 | ZEUS-P STRAIGHT SIZER, 7MM |
| 00840916159535 | ZEUS-T BULLET-NOSE TRIAL, 15 X 28MM |
| 00840916159528 | ZEUS-T BULLET-NOSE TRIAL, 14 X 28MM |
| 00840916159511 | ZEUS-T BULLET-NOSE TRIAL, 13 X 28MM |
| 00840916159504 | ZEUS-T BULLET-NOSE TRIAL, 12 X 28MM |
| 00840916159498 | ZEUS-T BULLET-NOSE TRIAL, 11 X 28MM |
| 00840916159481 | ZEUS-T BULLET-NOSE TRIAL, 10 X 28MM |
| 00840916159474 | ZEUS-T BULLET-NOSE TRIAL, 9 X 28MM |
| 00840916159467 | ZEUS-T BULLET-NOSE TRIAL, 8 X 28MM |
| 00840916159450 | ZEUS-T BULLET-NOSE TRIAL, 7 X 28MM |
| 00840916159443 | BULLET NOSE TLIF TRIAL HANDLE |
| 00840916155681 | STRAIGHT HANDLE, HUDSON, STATIC, SLAP HAMMER |
| 00840916155568 | T-HANDLE |
| 00840916161453 | TUBE TLIF TRIALS 36L X 15H |
| 00840916161446 | TUBE TLIF TRIALS 36L X 14H |
| 00840916161439 | TUBE TLIF TRIALS 36L X 13H |
| 00840916161422 | TUBE TLIF TRIALS 36L X 12H |
| 00840916161415 | TUBE TLIF TRIALS 36L X 11H |
| 00840916161408 | TUBE TLIF TRIALS 36L X 10H |
| 00840916161392 | TUBE TLIF TRIALS 36L X 09H |
| 00840916161385 | TUBE TLIF TRIALS 36L X 08H |
| 00840916161378 | TUBE TLIF TRIALS 36L X 07H |
| 00840916161361 | TUBE TLIF TRIALS 28L X 15H |
| 00840916161354 | TUBE TLIF TRIALS 28L X 14H |
| 00840916161347 | TUBE TLIF TRIALS 28L X 13H |
| 00840916161330 | TUBE TLIF TRIALS 28L X 12H |
| 00840916161323 | TUBE TLIF TRIALS 28L X 11H |
| 00840916161316 | TUBE TLIF TRIALS 28L X 10H |
| 00840916161309 | TUBE TLIF TRIALS 28L X 09H |
| 00840916161293 | TUBE TLIF TRIALS 28L X 08H |
| 00840916161286 | TUBE TLIF TRIALS 28L X 07H |
| 00840916161279 | NON-INSULATED LATERAL DILATOR SIX |
| 00840916161262 | NON-INSULATED LATERAL DILATOR FIVE |
| 00840916161255 | NON-INSULATED LATERAL DILATOR FOUR GROOVED |
| 00840916161248 | NON-INSULATED LATERAL DILATOR FOUR |
| 00840916161231 | NON-INSULATED LATERAL DILATOR THREE |
| 00840916161224 | NON-INSULATED LATERAL DILATOR TWO |