Passer
SET Screw FOR Suture Passer, Small. Meniscal Mender II
6manufacturers in China registered for this device type
13catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Anqing Changfan Medical Instrument Co., Ltd. | Anqing | Anhui | Manufacturer | 9 |
| Qingdao Zhixing Medical Instrument Co., Ltd. | Qingdao | Shandong | Manufacturer | 6 |
| Dongguan Senmed Medical Instrument Co., Ltd. | Dongguar | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | HWQ |
| Device type | Passer |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K885311 |
| Record published | 2015-08-30 |
| Record revised | 2023-09-07 (version 8) |
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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2022-03-17 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7209483 | In distribution | |
| 013646 | In distribution | |
| 7209480 | In distribution | |
| 3134100 | In distribution | |
| 7209536 | In distribution | |
| 014395 | In distribution | |
| 71935643 | In distribution | |
| E0015647-1 | In distribution | |
| 7209485 | In distribution | |
| 7210752 | In distribution | |
| 6900921 | Withdrawn | |
| 3134077 | Withdrawn | |
| 1107489 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex | Provision | 76 |
| Medline | Medline Industries, Inc. | 32 |
| Conmed/Linvatec | Provision | 24 |
| Stryker | Provision | 22 |
| Cylox ST | Signus Medizintechnik Gmbh | 16 |
| Apex | Stryker GmbH | 16 |
| EZ Pass | Biomet Orthopedics | 14 |
| gSource | Gsource, LLC. | 12 |
| Millennium | Avalign Technologies, Inc. | 11 |
| Medline Renewal | Medline Industries, Inc. | 9 |
| EZPass™ | Biomet Orthopedics | 7 |
| Speedpass Disposable | Biomet Orthopedics | 7 |
Showing 12 of 130. All products under Passer
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.