| Primary Device ID | 00840916150068 |
| NIH Device Record Key | e7b04f39-a235-4660-8f5a-1836411bc110 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Savannah |
| Version Model Number | 692100 |
| Company DUNS | 004022104 |
| Company Name | SPINAL ELEMENTS |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 00840916150068 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
[00840916150068]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-24 |
| Device Publish Date | 2020-04-16 |
| 00840916135836 | 90° CURVED ROD INSERTER BODY |
| 00840916135829 | 90° CURVED ROD INSERTER SHAFT |
| 00840916155919 | IMP PLATE FOR LO-TOP/MID-TOP TRAY BOTTOM LEVEL |
| 00840916155902 | IMP PLATE FOR LO-TOP/MID-TOP TRAY |
| 00840916149901 | DUAL FIX SCREW CADDY |
| 00840916160722 | K-WIRE TUBE |
| 00840916160715 | INGE LAMINA SPREADER, LARGE 10" |
| 00840916160692 | NOTCHED PEDICLE MARKER |
| 00840916160685 | SOLID PEDICLE MARKER |
| 00840916155926 | DUAL STYLET NEEDLE, DIAMOND AND BEVEL TIP, 11 G X 15CM |
| 00840916151669 | LARGE T-HANDLE WITH AO CONNECTION GAUTHIER (G308532) |
| 00840916151645 | ROD INSERTER DRIVER |
| 00840916151454 | PEDICLE DRILL GUIDE |
| 00840916150938 | DRILL GUIDE, MIDLINE |
| 00840916150303 | COMBINATION, PEDICLE-DRILL |
| 00840916150297 | PEDICLE-DRILL, MIDLINE |
| 00840916150280 | SET SCREW INSERTER |
| 00840916150273 | MIS CONNECTOR INSERTER |
| 00840916150266 | ROD BENDER |
| 00840916150259 | AXIAL HANDLE - RATCHETING |
| 00840916150242 | T-HANDLE |
| 00840916150235 | TORQUE LIMITING T-HANDLE |
| 00840916150228 | PEDICLE FEELER |
| 00840916150211 | COUPLER PUSHER ASSEMBLY |
| 00840916150204 | STABILIZER |
| 00840916150198 | CANNULATED TAP |
| 00840916150181 | CANNULATED TAP WITH QUICK CONNECT |
| 00840916150174 | CANNULATED TAP |
| 00840916150167 | HEX RETAINER |
| 00840916150150 | CANNULATED HEX DRIVER |
| 00840916150143 | CROW FOOT SIDEBAR |
| 00840916150136 | CROW FOOT |
| 00840916150129 | SQUARE DRIVER |
| 00840916150112 | FLUTED AWL |
| 00840916150105 | TAPPING AWL |
| 00840916150099 | HEX DRIVER |
| 00840916150082 | POST REMOVER |
| 00840916150075 | 8.5" PLUNGER |
| 00840916150068 | STRAIGHT ROD HOLDING FORCEPS 5.5MM |
| 00840916150051 | MISCELLANEOUS CADDY 4.00 X 7.40 X 1.13IN |
| 00840916149840 | HEX ADAPTER |
| 00840916160777 | SAVANNAH-T MIS PEDICLE SCREW TAP 6.5MM |
| 00840916160753 | MEDIAL SET SCREW SLEEVE |
| 00840916160746 | COMBINATION ROD BENDERS RIGHT |
| 00840916160739 | COMBINATION ROD BENDERS LEFT |
| 00840916150440 | 90° CURVED ROD INSERTER |
| 00840916150433 | SHORT RIGHT ANGLE ROD INSERTER |
| 00840916150426 | SET SCREW DRIVER WITH FRICTION FIT |
| 00840916150419 | MIS TULIP POSITIONER |
| 00840916150396 | 18 INCH PEDICLE SCREW DEPTH GAUGE |