Response 4.5/5.0 Spine System
Hook Pusher, Hook Mating
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
Record
| Listed by | Orthopediatrics, Corp, United States |
|---|---|
| FDA product code | KIK |
| Device type | Hook, Bone |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-03-05 |
| Record revised | 2025-07-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-1600-6158 | In distribution | |
| 01-1600-6159 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HNM Medical | HNM Stainless, LLC. | 65 |
| Millennium | Avalign Technologies, Inc. | 34 |
| Innomed, Inc. | Innomed, Inc. | 18 |
| gSource | Gsource, LLC. | 18 |
| Avalign | Avalign Technologies, Inc. | 14 |
| General Instrument | Orthopediatrics, Corp | 13 |
| Boss Instruments | Boss Instruments, Ltd. | 13 |
| Orthomed | Ortho-MED, Inc. | 13 |
| Ambler Surgical | Ambler Surgical, LLC | 12 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 10 |
| Novo Surgical | Novo Surgical, Inc. | 9 |
| Kmedic | Teleflex Medical LLC | 8 |
Showing 12 of 54. All products under Hook, Bone
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.