| Primary Device ID | 00841132152225 |
| NIH Device Record Key | c96183e2-e180-467b-adca-f4425572f61f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Response 4.5/5.0 Spine System |
| Version Model Number | 00-1600-2627 |
| Catalog Number | 00-1600-2627 |
| Company DUNS | 796416191 |
| Company Name | ORTHOPEDIATRICS CORP. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841132152225 [Primary] |
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
[00841132152225]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-13 |
| Device Publish Date | 2020-03-05 |
| 00841132173367 | 4.5/5.0 Hook & Connector - Caddy |
| 00841132173350 | 4.5/5.0 Pedicle Prep and Final Drive - Tray 3 |
| 00841132173343 | Transition Case - Tray 2 |
| 00841132173336 | 4.5/5.0 Hook & Connector - Tray 2 |
| 00841132173329 | Derotation Tray 1 |
| 00841132173312 | 4.5/5.0 Correction Tray 1 |
| 00841132173305 | 4.5/5.0 Rod and Rod Reduction - Tray 2 |
| 00841132173299 | 4.5/5.0 Polyaxial Reduction Screws - Caddy 2 |
| 00841132173282 | 4.5/5.0 Polyaxial Screws - Caddy 2 |
| 00841132173275 | 4.5/5.0 Pedicle Prep and Final Drive - Tray 2 |
| 00841132173268 | Transition Case - Tray 1 |
| 00841132173251 | 4.5/5.0 Hook & Connector - Tray 1 |
| 00841132173244 | Derotation Tray 2 |
| 00841132173237 | 4.5/5.0 Correction Tray 2 |
| 00841132173220 | 4.5/5.0 Rod and Rod Reduction - Tray 1 |
| 00841132173213 | 4.5/5.0 Uniaxial Reduction Screws - Caddy 1 |
| 00841132173206 | 4.5/5.0 Uniaxial Screws - Caddy 1 |
| 00841132173190 | 4.5/5.0 Pedicle Prep and Final Drive - Tray 1 |
| 00841132173183 | 4.5/5.0 Large Set Screw Caddy |
| 00841132173176 | 4.5/5.0 Case Base |
| 00841132156995 | T15 DRIVER |
| 00841132156988 | LARGE SET SCREW DRIVER |
| 00841132156971 | LARGE SET SCREW DRIVER, FINAL |
| 00841132156964 | 4.5/5.0 Tower |
| 00841132156957 | Flat Rod Bender, Right |
| 00841132156940 | Flat Rod Bender, Left |
| 00841132156933 | X-LINK SELECTOR (CALIPER) |
| 00841132156926 | HOOK HOLDER, CURVED STR. |
| 00841132156919 | HOOK HOLDER, CURVED LAT. |
| 00841132156902 | ROD WRENCH |
| 00841132156896 | HEAD POSITIONER |
| 00841132156889 | BONE PLANAR |
| 00841132156872 | REDUCTION PEDICLE SCREW DRIVER, HUDSON |
| 00841132156865 | PEDICLE SCREW DRIVER, HUDSON |
| 00841132156858 | HOOK PUSHER, C-SHAPED |
| 00841132156841 | HOOK PUSHER, HOOK MATING |
| 00841132156834 | HOOK HOLDER, STRAIGHT |
| 00841132156827 | COUNTER TORQUE TUBE |
| 00841132156810 | REDUCTION PEDICLE SCREW DRIVER, Power |
| 00841132156803 | PEDICLE SCREW DRIVER, Power |
| 00841132156797 | DISTRACTOR |
| 00841132156780 | COMPRESSOR, SMALL |
| 00841132156773 | ROCKER |
| 00841132156766 | REDUCTION PEDICLE SCREW DRIVER |
| 00841132156759 | PEDICLE SCREW DRIVER |
| 00841132156742 | TAB BREAKER |
| 00841132156735 | Mini Rod Reducer |
| 00841132156728 | 4.5/5.0 Lid |
| 00841132156711 | Rod Cutter Case |
| 00841132156704 | 4.5/5.0 Unique Instruments |