| Primary Device ID | 00841132187357 |
| NIH Device Record Key | fc2b06e0-849d-423f-91e2-08202f0bca31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Response 5.5/6.0 |
| Version Model Number | 01-1301-1085 |
| Catalog Number | 01-1301-1085 |
| Company DUNS | 796416191 |
| Company Name | ORTHOPEDIATRICS CORP. |
| 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 | 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 |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841132187357 [Primary] |
| KIJ | Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841132187357]
Moist Heat or Steam Sterilization
[00841132187357]
Moist Heat or Steam Sterilization
[00841132187357]
Moist Heat or Steam Sterilization
[00841132187357]
Moist Heat or Steam Sterilization
[00841132187357]
Moist Heat or Steam Sterilization
[00841132187357]
Moist Heat or Steam Sterilization
[00841132187357]
Moist Heat or Steam Sterilization
[00841132187357]
Moist Heat or Steam Sterilization
[00841132187357]
Moist Heat or Steam Sterilization
[00841132187357]
Moist Heat or Steam Sterilization
[00841132187357]
Moist Heat or Steam Sterilization
[00841132187357]
Moist Heat or Steam Sterilization
[00841132187357]
Moist Heat or Steam Sterilization
[00841132187357]
Moist Heat or Steam Sterilization
[00841132187357]
Moist Heat or Steam Sterilization
[00841132187357]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-28 |
| Device Publish Date | 2025-05-20 |
| 00841132191149 | 5.5/6.0 Open/ Open domino connector |
| 00841132191132 | 5.5/6.0 Open/ Closed wedding band |
| 00841132191125 | 5.5/6.0 Open/ Open wedding band connector, 20mm |
| 00841132191118 | 5.5/6.0 Open/ Open wedding band connector, 15mm |
| 00841132191101 | 5.5/6.0 Open/ Open wedding band connector, 10mm |
| 00841132191095 | 5.5/6.0 double open lateral connector, 80mm |
| 00841132191088 | 5.5/6.0 double open lateral connector, 60mm |
| 00841132191071 | 5.5/6.0 double open lateral connector, 40mm |
| 00841132191064 | 5.5/6.0 closed lateral connector, 60mm |
| 00841132191057 | 5.5/6.0 closed lateral connector, 40mm |
| 00841132191040 | 5.5/6.0 closed lateral connector, 20mm |
| 00841132191033 | 5.5/6.0 closed stopper |
| 00841132178911 | 5.5/6.0 Elevated polyaxial lateral connector, 40mm |
| 00841132178898 | 5.5/6.0 Elevated polyaxial lateral connector, 20mm |
| 00840194405287 | 5.5/6.0 2 screw open lateral, 20mm |
| 00840194405270 | 5.5/6.0 closed lateral connector, 80mm |
| 00841132187371 | 9.5mm Cannulated Tap |
| 00841132187364 | 9mm Cannulated Tap |
| 00841132187357 | 8.5mm Cannulated Tap |
| 00841132187340 | 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 10.5MM X 110MM |
| 00841132187333 | 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 10.5MM X 100MM |
| 00841132187326 | 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 10.5MM X 90MM |
| 00841132187319 | 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 10.5MM X 80MM |
| 00841132187302 | 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 10MM X 110MM |
| 00841132187296 | 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 10MM X 100MM |
| 00841132187289 | 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 10MM X 90MM |
| 00841132187272 | 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 10MM X 80MM |
| 00841132187265 | 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 9.5MM X 110MM |
| 00841132187258 | 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 9.5MM X 100MM |
| 00841132187241 | 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 9.5MM X 90MM |
| 00841132187234 | 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 9.5MM X 80MM |
| 00840194418461 | 5.5/6.0 SI Fixation Implant Caddy |
| 00840194418294 | 5.5/6.0 SI Fixation Caddy |
| 00840194418270 | Tap 10.5mm, Cannulated, ZH Connect |
| 00840194418263 | Tap 10mm, Cannulated, ZH Connect |