Reamer
135 catalogue numbers from 4033-21, 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
135catalogue 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 | 2016-07-26 |
| Record revised | 2023-10-04 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Lumen/inner diameter 3.2 mm; outer diameter 5 mm; length 7 mm; length 4.5 in |
| Distribution end date | 2017-06-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4033-21 | In distribution | |
| 1179-42 | Lumen/Inner Diameter 3.2 mm | In distribution |
| 6265-03-225 | Size 22.5 mm | In distribution |
| 807-01 | 2.4 mm Diameter | In distribution |
| 5979-77-46 | 46 mm Diameter | In distribution |
| 5979-77-01 | Length 7 mm | In distribution |
| 5120-70-26 | 26 mm Diameter | In distribution |
| 9801-44 | Size 4 | In distribution |
| 5979-77-41 | 41 mm Diameter | In distribution |
| 9801-43 | Size 3 | In distribution |
| 9801-45 | Size 5 | In distribution |
| 5979-77-32 | 32 mm Diameter | In distribution |
| 6265-03-145 | Size 14.5 mm | In distribution |
| 5979-77-38 | 38 mm Diameter | In distribution |
| 31-8106-168 | Length 4.5 in | In distribution |
| 9801-32 | In distribution | |
| 6265-03-165 | Size 16.5 mm | In distribution |
| 5979-77-51 | 51 mm Diameter | In distribution |
| 78.00.38-22 | In distribution | |
| 7880-10-000 | Size 0 | In distribution |
| 6265-03-205 | Size 20.5 mm | In distribution |
| 6265-03-185 | Size 18.5 mm | In distribution |
| 6265-03-105 | Size 10.5 mm | In distribution |
| 5979-95-51 | 51 mm Diameter | In distribution |
| 9801-46 | Size 6 | In distribution |
| 5979-95-29 | 29 mm Diameter | In distribution |
| 5979-95-32 | 32 mm Diameter | In distribution |
| 6890-03-004 | Size 3-5 | In distribution |
| 5979-95-38 | 38 mm Diameter | In distribution |
| 5979-95-26 | 26 mm Diameter | In distribution |
| 5979-77-35 | 35 mm Diameter | In distribution |
| 5979-95-46 | 46 mm Diameter | In distribution |
| 6265-03-125 | Size 12.5 mm | In distribution |
| 6601-35 | In distribution | |
| 5120-79 | 10/12 mm | In distribution |
| 5011-08 | In distribution | |
| 5979-77-29 | 29 mm Diameter | In distribution |
| 9801-42 | Size 2 | In distribution |
| 5979-95-41 | 41 mm Diameter | In distribution |
| 5979-95-35 | 35 mm Diameter | In distribution |
| 5120-78 | 8/10 mm | In distribution |
| 5979-77-26 | 26 mm Diameter | In distribution |
| 9801-41 | Size 1 | In distribution |
| 9200-02-066 | Size 66 mm | Withdrawn |
| 9275-00-052 | 52 mm | Withdrawn |
| 9200-02-054 | Size 54 mm | Withdrawn |
| 9200-02-070 | Size 70 mm | Withdrawn |
| 9275-00-055 | 55 mm | Withdrawn |
| 9200-02-078 | Size 78 mm | Withdrawn |
| 9354-20-003 | Size 3 | Withdrawn |
| 9275-00-043 | 43 mm | Withdrawn |
| 9275-00-068 | 68 mm | Withdrawn |
| 9200-02-037 | Size 37 mm | Withdrawn |
| 9275-00-059 | 59 mm | Withdrawn |
| 9200-02-069 | Size 69 mm | Withdrawn |
| 9275-00-054 | 54 mm | Withdrawn |
| 9200-02-074 | Size 74 mm | Withdrawn |
| 9200-02-043 | Size 43 mm | Withdrawn |
| 9354-20-005 | Size 5 | Withdrawn |
| 9354-20-006 | Size 6 | Withdrawn |
| 9275-00-058 | 58 mm | Withdrawn |
| 9275-00-050 | 50 mm | Withdrawn |
| 9200-02-063 | Size 63 mm | Withdrawn |
| 9200-02-073 | Size 73 mm | Withdrawn |
| 7803-50-11 | 11 mm | Withdrawn |
| 7803-50-15 | 15 mm | Withdrawn |
| 9275-00-071 | 71 mm | Withdrawn |
| 9275-00-042 | 42 mm | Withdrawn |
| 9200-02-061 | Size 61 mm | Withdrawn |
| 9200-02-060 | Size 60 mm | Withdrawn |
| 9400-99-230 | Withdrawn | |
| 9200-02-053 | Size 53 mm | Withdrawn |
| 9200-02-059 | Size 59 mm | Withdrawn |
| 9200-02-046 | Size 46 mm | Withdrawn |
| 9275-00-048 | 48 mm | Withdrawn |
| 9200-02-055 | Size 55 mm | Withdrawn |
| 9200-02-080 | Size 80 mm | Withdrawn |
| 9200-02-067 | Size 67 mm | Withdrawn |
| 9275-00-063 | 63 mm | Withdrawn |
| 9354-20-010 | Withdrawn | |
| 9200-02-071 | Size 71 mm | Withdrawn |
| 7803-50-17 | 17 mm | Withdrawn |
| 9200-02-058 | Size 58 mm | Withdrawn |
| 9200-02-041 | Size 41 mm | Withdrawn |
| 9200-02-042 | Size 42 mm | Withdrawn |
| 9275-00-069 | 69 mm | Withdrawn |
| 9200-02-050 | Size 50 mm | Withdrawn |
| 9275-00-044 | 44 mm | Withdrawn |
| 9200-02-079 | Size 79 mm | Withdrawn |
| 9275-00-046 | 46 mm | Withdrawn |
| 9275-00-057 | 57 mm | Withdrawn |
| 9200-02-076 | Size 76 mm | Withdrawn |
| 6890-03-003 | Size 0-2 | Withdrawn |
| 9200-02-062 | Size 62 mm | Withdrawn |
| 9354-20-000 | Size 0 | Withdrawn |
| 9275-00-051 | 51 mm | Withdrawn |
| 9275-00-053 | 53 mm | Withdrawn |
| 9275-00-070 | 70 mm | Withdrawn |
| 9200-02-065 | Size 65 mm | Withdrawn |
| 9200-02-038 | Size 38 mm | Withdrawn |
| 9275-00-064 | 64 mm | Withdrawn |
| 9200-02-056 | Size 56 mm | Withdrawn |
| 9354-20-002 | Size 2 | Withdrawn |
| 9275-00-049 | 49 mm | Withdrawn |
| 9275-00-065 | 65 mm | Withdrawn |
| 7803-50-09 | 9 mm | Withdrawn |
| 9200-02-044 | Size 44 mm | Withdrawn |
| 9200-02-075 | Size 75 mm | Withdrawn |
| 9275-00-061 | 61 mm | Withdrawn |
| 9200-02-040 | Size 40 mm | Withdrawn |
| 9200-02-057 | Size 57 mm | Withdrawn |
| 9200-02-052 | Size 52 mm | Withdrawn |
| 9200-02-039 | Size 39 mm | Withdrawn |
| 9200-02-049 | Size 49 mm | Withdrawn |
| 9200-02-077 | Size 77 mm | Withdrawn |
| 9275-00-047 | 47 mm | Withdrawn |
| 9200-02-064 | Size 64 mm | Withdrawn |
| 9275-00-062 | 62 mm | Withdrawn |
| 9354-20-001 | Size 1 | Withdrawn |
| 9354-20-004 | Size 4 | Withdrawn |
| 9275-00-066 | 66 mm | Withdrawn |
| 9200-02-068 | Size 68 mm | Withdrawn |
| 9200-02-045 | Size 45 mm | Withdrawn |
| 9200-02-047 | Size 47 mm | Withdrawn |
| 9200-02-072 | Size 72 mm | Withdrawn |
| 9200-02-051 | Size 51 mm | Withdrawn |
| 7803-50-13 | 13 mm | Withdrawn |
| 9275-00-045 | 45 mm | Withdrawn |
| 9400-99-231 | Withdrawn | |
| 9275-00-067 | 67 mm | Withdrawn |
| 9400-99-232 | Withdrawn | |
| 9200-02-048 | Size 48 mm | Withdrawn |
| 9275-00-056 | 56 mm | Withdrawn |
| 9275-00-060 | 60 mm | Withdrawn |
| 9352-02-110 | Size 00 | Withdrawn |
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 |
| Endo-Model Knee System – Instruments | Waldemar Link GmbH & Co. KG | 109 |
| DJO Surgical | Encore Medical, L.P. | 108 |
| Arthrex® | Arthrex, Inc. | 105 |
| Arthrex | Provision | 98 |
Showing 12 of 1,224. All products under Reamer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K954915 | 1995-12-28 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 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.