Identity™
40 catalogue numbers from SBHS0209, listed by Zimmer, Inc., United States, under Reamer. 23 manufacturers in China are registered for this product code.
23manufacturers in China registered for this device type
40catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (6), Zhejiang (3). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Changzhou Master Precision Tool Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Showing 12 of 23. All 23 manufacturers in China registered for Reamer
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | HTO |
| Device type | Reamer |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-09-22 |
| Record revised | 2023-05-30 (version 5) |
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 |
|---|---|---|
| SBHS0209 | Size 9 | In distribution |
| SBHS0314 | Size 14 | In distribution |
| SBHS0316 | Size 16 | In distribution |
| SBHS0215 | Size 15 | In distribution |
| SBHS0312 | Size 12 | In distribution |
| SBHS0205 | Size 5 | In distribution |
| SBHS0212 | Size 12 | In distribution |
| SBHS0318 | Size 18 | In distribution |
| SBHS0307 | Size 7 | In distribution |
| SBHS0220 | Size 20 | In distribution |
| SBHS0210 | Size 10 | In distribution |
| SBHA4040 | 40mm | In distribution |
| SBHS0217 | Size 17 | In distribution |
| SBHA4045 | 45mm | In distribution |
| SBHS0211 | Size 11 | In distribution |
| SBHA4035 | 35mm | In distribution |
| SBHS0311 | Size 11 | In distribution |
| SBHS0213 | Size 13 | In distribution |
| SBHS0317 | Size 17 | In distribution |
| SBHS0315 | Size 15 | In distribution |
| SBHS0306 | Size 6 | In distribution |
| SBHS0319 | Size 19 | In distribution |
| SBHT0000 | In distribution | |
| SBHS0208 | Size 8 | In distribution |
| SBHS0207 | Size 7 | In distribution |
| SBHS0304 | Size 4 | In distribution |
| SBHA4055 | 55mm | In distribution |
| SBHA4050 | 50mm | In distribution |
| SBHS0313 | Size 13 | In distribution |
| SBHS0310 | Size 10 | In distribution |
| SBHS0309 | Size 9 | In distribution |
| SBHS0206 | Size 6 | In distribution |
| SBHS0218 | Size 18 | In distribution |
| SBHS0214 | Size 14 | In distribution |
| SBHS0216 | Size 16 | In distribution |
| SBHA4000 | In distribution | |
| SBHS0219 | Size 19 | In distribution |
| SBHS0308 | Size 8 | In distribution |
| SBHS0320 | Size 20 | In distribution |
| SBHS0305 | Size 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trigen | Smith & Nephew, Inc. | 1,029 |
| Viant Medical, LLC | Viant Medical, LLC | 825 |
| R3 | Smith & Nephew, Inc. | 287 |
| Reamer | Ortho Development Corp. | 259 |
| InSitu Hip System | Nextstep Arthropedix | 181 |
| Apex Knee System | Omni Life Science, Inc. | 162 |
| Reamer | Synthes Gmbh | 152 |
| Reclaim | Depuy (Ireland) | 138 |
| Reamer | Zimmer, Inc. | 135 |
| Endo-Model Knee System – Instruments | Waldemar Link GmbH & Co. KG | 109 |
| DJO Surgical | Encore Medical, L.P. | 108 |
| Arthrex® | Arthrex, Inc. | 105 |
Showing 12 of 1,224. All products under Reamer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K954915 | 1995-12-28 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Zimmer, Inc. | UDI-DI | 2022-12-07 | Class II | Process control | Two planers were found to be unusable during sawbones shoulder training. | 84 units |
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.