Response Spine
Component Part, NOT Sold Under This Part Number
7manufacturers in China registered for this device type
19catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (4), Shandong (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Orthopediatrics, Corp, United States |
|---|---|
| FDA product code | OSH |
| Device type | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K160466 |
| Record published | 2016-10-31 |
| Record revised | 2025-07-02 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2021-09-29 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-1300-6156 | In distribution | |
| 00-1003-5554 | In distribution | |
| 01-1003-8507 | In distribution | |
| 00-1003-4369 | In distribution | |
| 00-1003-5553 | In distribution | |
| 01-1300-6154 | In distribution | |
| 01-1300-5611 | In distribution | |
| 01-1003-8504 | In distribution | |
| 01-1003-8506 | In distribution | |
| 01-1003-8505 | In distribution | |
| 01-1003-8510 | In distribution | |
| 01-1003-8509 | In distribution | |
| 00-1003-4301 | In distribution | |
| 01-1003-8501 | In distribution | |
| 00-1003-4335 | In distribution | |
| 01-1300-6155 | In distribution | |
| 01-1003-8500 | In distribution | |
| 01-1003-8508 | In distribution | |
| 00-1003-5554 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Creo | Globus Medical, Inc. | 1,821 |
| ReLine | Nuvasive, Inc. | 1,093 |
| Olympic | Astura Medical | 951 |
| Nex-D2 | Next Orthosurgical | 887 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 876 |
| Arsenal | Alphatec Spine, Inc. | 820 |
| Apex-DL Spine System | Spinecraft LLC | 691 |
| Polaris™ 4.75 Spinal System | Biomet Spine | 413 |
| Expedium | Medos International Sàrl | 400 |
| Implanet Spine System | Implanet | 386 |
| Everest® Spinal System | VB Spine LLC | 299 |
| Arsenal Deformity Spinal Fixation System | Alphatec Spine, Inc. | 258 |
Showing 12 of 73. All products under Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130655 | 2013-05-08 |
| K121250 | 2012-06-19 |
| K120291 | 2012-04-16 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-08-03 | Class II | Employee error | The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws. | 24 units | 2019-05-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.