Natural Nail®
Catalogue number 00-2490-021-00, listed by Zimmer, Inc., United States, under Pusher, Socket. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | HXO |
| Device type | Pusher, Socket |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-11-30 |
| Record revised | 2023-05-03 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-2490-021-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spirofit Pinnacle | Depuy (Ireland) | 17 |
| Pinnacle | Depuy (Ireland) | 14 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 14 |
| Pusher, Socket | Zimmer, Inc. | 11 |
| Mega Spine System | BK Meditech Co., Ltd. | 9 |
| Kheiron | S.m.a.i.o | 5 |
| MEGA5.5 Spine System | BK Meditech Co., Ltd. | 5 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 4 |
| Link Instruments – Fixation instruments | Waldemar Link GmbH & Co. KG | 3 |
| Affiniti | Tornier Inc. | 3 |
| Liner Pusher Head | Biomet UK Ltd. | 3 |
| Pusher, Socket | Doppkon Gmbh & Co. KG | 3 |
Showing 12 of 58. All products under Pusher, Socket
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K803165 | 1980-12-31 |
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.