| Primary Device ID | 00840916161545 | 
| NIH Device Record Key | c220769b-c711-45fe-b261-5da0727bdc3d | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | ZEUS-T | 
| Version Model Number | 11104-014 | 
| 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 | 00840916161545 [Primary] | 
| LXH | Orthopedic Manual Surgical Instrument | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
[00840916161545]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-02-09 | 
| Device Publish Date | 2021-02-01 | 
| 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 |