| Primary Device ID | 00840916161712 |
| NIH Device Record Key | 6e60d1f1-3387-4af5-8642-9761028bec24 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZEUS-A |
| Version Model Number | PI-1219 |
| 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 | 00840916161712 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
[00840916161712]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-16 |
| Device Publish Date | 2021-03-08 |
| 00840916159184 | ZEUS-A CAGE, 42W X 25DP X 22H, 7 DEGREE (EXTRA WIDE 1 THREAD) |
| 00840916159177 | ZEUS-A CAGE, 42W X 25DP X 20H, 7 DEGREE (EXTRA WIDE 1 THREAD) |
| 00840916159160 | ZEUS-A CAGE, 42W X 25DP X 18H, 7 DEGREE (EXTRA WIDE 1 THREAD) |
| 00840916159153 | ZEUS-A CAGE, 42W X 25DP X 16H, 7 DEGREE (EXTRA WIDE 1 THREAD) |
| 00840916159146 | ZEUS-A CAGE, 42W X 25DP X 14H, 7 DEGREE (EXTRA WIDE 1 THREAD) |
| 00840916159139 | ZEUS-A CAGE, 42W X 25DP X 12H,7 DEGREE (EXTRA WIDE 1 THREAD) |
| 00840916159122 | ZEUS-A CAGE, 42W X 25DP X 10H, 7 DEGREE (EXTRA WIDE 1 THREAD) |
| 00840916159115 | ZEUS-A CAGE, 42W X 25DP X 08H, 7 DEGREE |
| 00840916158613 | ZEUS-A TAMP |
| 00840916159924 | ANGLED ALIF TAMP |
| 00840916159894 | ANTERIOR LUMBAR PLATE INSERTER INTEGRATED DRILL GUIDE |
| 00840916159870 | 42MM LOLIPOP TRIALS |
| 00840916159757 | ZEUS-A BROACH HEAD, 16MM -7° |
| 00840916159740 | ZEUS-A BROACH HEAD, 14MM -7° |
| 00840916159733 | ZEUS-A BROACH HEAD, 12MM -7° |
| 00840916159726 | ZEUS-A BROACH HEAD, 10MM -7° |
| 00840916159719 | ZEUS-A BROACH HEAD, 8MM -7° |
| 00840916159702 | ZEUS-A OSTEOTOME, 16MM WIDE |
| 00840916159696 | ZEUS-A OSTEOTOME, 14MM WIDE |
| 00840916159689 | ZEUS-A OSTEOTOME, 10MM WIDE |
| 00840916159672 | ZEUS-A OSTEOTOME, 8MM WIDE |
| 00840916159665 | ZEUS-A ANTERIOR LUMBAR TRIAL, 14MM - 7° |
| 00840916159658 | ZEUS-A ANTERIOR LUMBAR TRIAL, 12MM - 7° |
| 00840916159641 | ZEUS-A ANTERIOR LUMBAR TRIAL, 8MM - 7° |
| 00840916159634 | ZEUS-A ANTERIOR LUMBAR TRIAL, 8MM - 7° |
| 00840916158491 | ZEUS-A POPSICLE TRIAL CONNECTED TO OBLIQUE HOLE |
| 00840916146474 | Zeus-A Cage Trial 42mm x 25mm x 22mm, 13° |
| 00840916146467 | Zeus-A Cage Trial 42mm x 25mm x 20mm, 13° |
| 00840916146450 | Zeus-A Cage Trial 42mm x 25mm x 18mm, 13° |
| 00840916146443 | Zeus-A Cage Trial 42mm x 25mm x 16mm, 13° |
| 00840916146436 | Zeus-A Cage Trial 42mm x 25mm x 14mm, 13° |
| 00840916146429 | Zeus-A Cage Trial 42mm x 25mm x 10mm, 7° |
| 00840916146412 | Zeus-A Cage Trial 42mm x 25mm x 10mm, 13° |
| 00840916146405 | Zeus-A Cage Trial 42mm x 25mm x 8mm, 13° |
| 00840916146399 | Zeus-A Cage Trial 42mm x 25mm x 22mm, 7° |
| 00840916146382 | Zeus-A Cage Trial 42mm x 25mm x 20mm, 7° |
| 00840916146375 | Zeus-A Cage Trial 42mm x 25mm x 18mm, 7° |
| 00840916146368 | Zeus-A Cage Trial 42mm x 25mm x 16mm, 7° |
| 00840916146351 | Zeus-A Cage Trial 42mm x 25mm x 14mm, 7° |
| 00840916146344 | Zeus-A Cage Trial 42mm x 25mm x 12mm, 7° |
| 00840916146337 | Zeus-A Cage Trial 42mm x 25mm x 10mm, 7° |
| 00840916146320 | Zeus-A Cage Trial 42mm x 25mm x 8mm, 7° |
| 00840916146313 | Zeus-A Cage 42mm x 25mm x 20mm, 13° |
| 00840916146306 | Zeus-A Cage 42mm x 25mm x 22mm, 7° |
| 00840916146290 | Zeus-A Cage 42mm x 25mm x 20mm, 7° |
| 00840916146283 | Zeus-A Inserter |
| 00840916146276 | Curved Chisel |
| 00840916146269 | ZEUS-A CADDY, 13 DEGREE |
| 00840916146252 | ZEUS-A CADDY, 7 DEGREE |
| 00840916146245 | Zeus-A Trial Handle |