Arrow Short Stem Humeral System
74 catalogue numbers from 272018- ARROW CALCAR PLANER D45, listed by Fournitures Hospitalieres Industrie, United States, under Shoulder Prosthesis, Reverse Configuration. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
74catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Stryker Trauson (Changzhou) Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Changzhou Atomic HI-Tech Radiation Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
Record
| Listed by | Fournitures Hospitalieres Industrie, United States |
|---|---|
| FDA product code | PHX |
| Device type | Shoulder Prosthesis, Reverse Configuration |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| 510(k) | K202024 |
| Record published | 2023-04-28 |
| Record revised | 2023-05-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2022-01-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 272018- ARROW CALCAR PLANER D45 | In distribution | |
| 271135- ARROW COMPACTEUR T4 | In distribution | |
| 271224- ARROW OSTEOTOME 4MM | In distribution | |
| 271925- MODULAR BROACH S2 ARROW | In distribution | |
| 271125- ARROW GABARIT T2 D8 | In distribution | |
| 271130- ARROW GUIDE BROCHE | In distribution | |
| 271133- ARROW COMPACTEUR T2 | In distribution | |
| 271144- ARROW TOURNEVIS DE SERRAGE | In distribution | |
| 271128- ARROW GABARIT T5 D14 | In distribution | |
| 271131- ARROW COMPACTEUR INITIAL | In distribution | |
| 272114- ARROW SHORT STEM COVER | In distribution | |
| 272044- ARROW SHORT REAMER D12 | In distribution | |
| 271924- MODULAR BROACH S1 ARROW | In distribution | |
| 271107- ARROW METAPHYSE SANS CIMENT T3 | In distribution | |
| 271105- ARROW METAPHYSE SANS CIMENT T1 | In distribution | |
| 271106- ARROW METAPHYSE SANS CIMENT T2 | In distribution | |
| 271142- ARROW DIAPHYSE D’ESSAI D14 | In distribution | |
| 272049- ARROW STANDARD SPACER FOR TRIAL METHAPHYSIS | In distribution | |
| 271136- ARROW COMPACTEUR T5 | In distribution | |
| 272039- ARROW SHORT REAMER D07 | In distribution | |
| 272019- ARROW CALCAR PLANER D50 | In distribution | |
| 271118- ARROW PANIER TIGE COURTE V1 | In distribution | |
| 271223- ARROW DIAPASON | In distribution | |
| 271126- ARROW GABARIT T3 D10 | In distribution | |
| 272017- ARROW CUTTING PROTECTOR D50 | In distribution | |
| 272046- ARROW SHORT REAMER D14 | In distribution | |
| 271127- ARROW GABARIT T4 D12 | In distribution | |
| 271225- ARROW IMPACTEUR DE PINS | In distribution | |
| 272040- ARROW SHORT REAMER D08 | In distribution | |
| 272023- ARROW CUTTING PROTECTOR D40 | In distribution | |
| 271139- ARROW DIAPHYSE D’ESSAI D8 | In distribution | |
| 272045- ARROW SHORT REAMER D13 | In distribution | |
| 271929- MODULAR BROACH S6 ARROW | In distribution | |
| 271145- ARROW PREHENSEUR POUR METAPHYSE | In distribution | |
| 271132- ARROW COMPACTEUR T1 | In distribution | |
| 271119- ARROW COUVERCLE UNIVERSEL | In distribution | |
| 271124- ARROW GABARIT T1 D6 | In distribution | |
| 271226- ARROW EXTRACTEUR DE METAPHYSE | In distribution | |
| 271100- ARROW TIGE DIAPHYSAIRE SANS CIMENT D8 L45 | In distribution | |
| 271109- ARROW METAPHYSE SANS CIMENT T5 | In distribution | |
| 272051- ARROW TRIAL DIAPHYSIS HOLDER | In distribution | |
| 272016- ARROW CUTTING PROTECTOR D45 | In distribution | |
| 271134- ARROW COMPACTEUR T3 | In distribution | |
| 272113- SHOULDER UNIVERSAL INSERT | In distribution | |
| 271926- MODULAR BROACH S3 ARROW | In distribution | |
| 272053- ARROW SHOULDER DISTRACTOR | In distribution | |
| 271123- ARROW ADAPTATEUR POUR GUIDE DE COUPE | In distribution | |
| 272038- ARROW SHORT REAMER D06 | In distribution | |
| 272050- ARROW ECCENTRIX SPACER FOR TRIAL METHAPHYSIS | In distribution | |
| 271141- ARROW DIAPHYSE D’ESSAI D12 | In distribution | |
| 272041- ARROW SHORT REAMER D09 | In distribution | |
| 271101- ARROW TIGE DIAPHYSAIRE SANS CIMENT D10 L45 | In distribution | |
| 271928- MODULAR BROACH S5 ARROW | In distribution | |
| 271140- ARROW DIAPHYSE D’ESSAI D10 | In distribution | |
| 271817 – ARROW BROCHE D3 L350 | In distribution | |
| 272047- ARROW SHORT REAMER D15 | In distribution | |
| 271923- ARROW QUICK-CONNECT BROACH HANDLE | In distribution | |
| 271110- ARROW METAPHYSE SANS CIMENT T6 | In distribution | |
| 272112- SHOULDER UNIVERSAL TRAY | In distribution | |
| 271102- ARROW TIGE DIAPHYSAIRE SANS CIMENT D12 L45 | In distribution | |
| 272042- ARROW SHORT REAMER D10 | In distribution | |
| 272048- ARROW SHORT REAMER D16 | In distribution | |
| 271108- ARROW METAPHYSE SANS CIMENT T4 | In distribution | |
| 271137- ARROW COMPACTEUR T6 | In distribution | |
| 271129- ARROW GABARIT T6 D16 | In distribution | |
| 271104- ARROW TIGE DIAPHYSAIRE SANS CIMENT D16 L45 | In distribution | |
| 272043- ARROW SHORT REAMER D11 | In distribution | |
| 271120- ARROW POINTE TROCART CANULEE | In distribution | |
| 272020- ARROW CALCAR PLANER D55 | In distribution | |
| 271927- MODULAR BROACH S4 ARROW | In distribution | |
| 271143- ARROW DIAPHYSE D’ESSAI D16 | In distribution | |
| 271103- ARROW TIGE DIAPHYSAIRE SANS CIMENT D14 L45 | In distribution | |
| 271099- ARROW TIGE DIAPHYSAIRE SANS CIMENT D6 L45 | Withdrawn | |
| 271138- ARROW DIAPHYSE D’ESSAI D6 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 297 |
| FX V135 | Fx Shoulder Solutions SAS | 131 |
| Prima TT Glenoid | Limacorporate | 129 |
| Shoulder Innovations Inset Reverse Total Shoulder | Shoulder Innovations, Inc | 124 |
| Equinoxe | Exactech, Inc. | 123 |
| Veritas rTSA | restor3d, inc. | 112 |
| DJO Surgical | Encore Medical, L.P. | 109 |
| R1 Reverse Shoulder System | Catalyst Orthoscience Inc | 100 |
| Tornier Perform™ Humeral System | Tornier Inc. | 96 |
| MSS – Monobloc stem | Medacta International SA | 92 |
| SMR Shoulder | Limacorporate | 90 |
| Humelock II Cemented Reversible Shoulder | Fx Solutions | 83 |
Showing 12 of 232. All products under Shoulder Prosthesis, Reverse Configuration
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K171789 | 2018-01-23 |
| K150568 | 2015-10-29 |
| K142778 | 2015-03-20 |
| K112193 | 2012-07-12 |
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.