| Primary Device ID | 00841132145753 |
| NIH Device Record Key | cdc30bea-043e-4832-bc23-90b656dc3caa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RESPONSE 5.5/6.0 Spine System |
| Version Model Number | 00-1600-0131 |
| Catalog Number | 00-1600-0131 |
| Company DUNS | 796416191 |
| Company Name | ORTHOPEDIATRICS CORP. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 |
| Phone | +1(574)268-6379 |
| Rzorn@OrthoPediatrics.com | |
| Phone | +1(574)268-6379 |
| bsmith@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| bsmith@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| bsmith@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| bsmith@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| bsmith@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| bsmith@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| bsmith@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| bsmith@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| bsmith@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| bsmith@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| bsmith@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| bsmith@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| bsmith@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| bsmith@orthopediatrics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841132145753 [Primary] |
| MNH | Orthosis, spondylolisthesis spinal fixation |
| NKB | Thoracolumbosacral pedicle screw system |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
[00841132145753]
Moist Heat or Steam Sterilization
[00841132145753]
Moist Heat or Steam Sterilization
[00841132145753]
Moist Heat or Steam Sterilization
[00841132145753]
Moist Heat or Steam Sterilization
[00841132145753]
Moist Heat or Steam Sterilization
[00841132145753]
Moist Heat or Steam Sterilization
[00841132145753]
Moist Heat or Steam Sterilization
[00841132145753]
Moist Heat or Steam Sterilization
[00841132145753]
Moist Heat or Steam Sterilization
[00841132145753]
Moist Heat or Steam Sterilization
[00841132145753]
Moist Heat or Steam Sterilization
[00841132145753]
Moist Heat or Steam Sterilization
[00841132145753]
Moist Heat or Steam Sterilization
[00841132145753]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-03-28 |
| 00084113213712 | SET SCREW TORQUE LIMITER, GRAY T-HANDLE 13 N-m |
| 00841132177679 | 5.5/6.0 - 40 DEG. OFFSET HOOK, Right 6.5mm |
| 00841132177662 | 5.5/6.0 - 40 DEG. OFFSET HOOK, Left 6.5mm |
| 00841132177655 | 5.5/6.0 - 40 DEG. OFFSET HOOK, Right 8mm |
| 00841132177648 | 5.5/6.0 - 40 DEG. OFFSET HOOK, Left 8mm |
| 00841132183694 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 85mm Length |
| 00841132183687 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 80mm Length |
| 00841132183670 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 75mm Length |
| 00841132183663 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 70mm Length |
| 00841132183656 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 65mm Length |
| 00841132183649 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 60mm Length |
| 00841132183632 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 55mm Length |
| 00841132183625 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 50mm Length |
| 00841132183618 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 45mm Length |
| 00841132183601 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 40mm Length |
| 00841132183595 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 35mm Length |
| 00841132183588 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 30mm Length |
| 00841132183571 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 25mm Length |
| 00841132183564 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 20mm Length |
| 00841132183557 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 75mm Length |
| 00841132183540 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 70mm Length |
| 00841132183533 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 65mm Length |
| 00841132183526 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 60mm Length |
| 00841132183519 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 55mm Length |
| 00841132183502 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 50mm Length |
| 00841132183496 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 45mm Length |
| 00841132183489 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 40mm Length |
| 00841132183472 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 35mm Length |
| 00841132183465 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 30mm Length |
| 00841132183458 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 25mm Length |
| 00841132183441 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 20mm Length |
| 00841132183434 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 4.5mm, 40mm Length |
| 00841132183427 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 4.5mm, 35mm Length |
| 00841132183410 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 4.5mm, 30mm Length |
| 00841132183403 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 4.5mm, 25mm Length |
| 00841132183397 | 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 4.5mm, 20mm Length |
| 00841132183380 | 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 85mm Length |
| 00841132183373 | 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 80mm Length |
| 00841132183366 | 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 75mm Length |
| 00841132183359 | 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 70mm Length |
| 00841132183342 | 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 65mm Length |
| 00841132183335 | 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 60mm Length |
| 00841132183328 | 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 55mm Length |
| 00841132183311 | 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 50mm Length |
| 00841132183304 | 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 45mm Length |
| 00841132183298 | 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 40mm Length |
| 00841132183281 | 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 35mm Length |
| 00841132183274 | 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 30mm Length |
| 00841132183267 | 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 25mm Length |
| 00841132183250 | 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 20mm Length |