Pinnacle
PINNACLE CERAMIC LINER INSERTER GRIPPER 54mm
6manufacturers in China registered for this device type
14catalogue numbers in this listing
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 | Depuy (Ireland), Ireland |
|---|---|
| FDA product code | HXO |
| Device type | Pusher, Socket |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-12-15 |
| Record revised | 2024-09-11 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2218-10-054 | In distribution | |
| 2218-10-036 | In distribution | |
| 2218-10-044 | In distribution | |
| 2218-10-062 | In distribution | |
| 2218-10-052 | In distribution | |
| 2218-10-056 | In distribution | |
| 2218-10-032 | In distribution | |
| 2218-10-064 | In distribution | |
| 2218-10-066 | In distribution | |
| 2218-10-060 | In distribution | |
| 2218-10-050 | In distribution | |
| 2218-10-058 | In distribution | |
| 2218-10-048 | In distribution | |
| 2218-10-028 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spirofit Pinnacle | Depuy (Ireland) | 17 |
| 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 |
| Pusher, Socket | Synthes Gmbh | 3 |
Showing 12 of 58. All products under Pusher, Socket
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.