PRO
Large Offset Jaw Clamp, Straight
24manufacturers in China registered for this device type
23catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Jiangsu (9), Zhejiang (5), Shanghai (4). 7 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 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Linhai Deyi Plastic Co., Ltd. | Linhai | Zhejiang | Contract manufacturer | 15 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Showing 12 of 24. All 24 manufacturers in China registered for Clamp
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HXD |
| Device type | Clamp |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
| Record revised | 2025-04-14 (version 6) |
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 |
|---|---|---|
| 705452 | In distribution | |
| 705457 | In distribution | |
| 705433 | In distribution | |
| 705461 | In distribution | |
| 705455 | In distribution | |
| 705459 | In distribution | |
| 705434 | In distribution | |
| 705456 | In distribution | |
| 705450 | In distribution | |
| 705464 | In distribution | |
| 705458 | In distribution | |
| 705451 | In distribution | |
| 705454 | In distribution | |
| 705432 | In distribution | |
| 705462 | In distribution | |
| 705465 | In distribution | |
| 705431 | In distribution | |
| 705435 | In distribution | |
| 705460 | In distribution | |
| 705430 | In distribution | |
| 705466 | In distribution | |
| 705453 | In distribution | |
| 705463 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Atraumata | Aesculap AG | 196 |
| Innomed, Inc. | Innomed, Inc. | 166 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 136 |
| Orthomed | Ortho-MED, Inc. | 115 |
| Aesculap | Aesculap AG | 110 |
| Surtex | Surtex Instruments Ltd | 93 |
| Lazic | Peter Lazic Gmbh | 91 |
| Clamp | Black & Black Surgical, Inc. | 81 |
| Ambler Surgical | Ambler Surgical, LLC | 77 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 60 |
| Pilling | Teleflex Medical LLC | 55 |
| American Medicals | American Medicals | 49 |
Showing 12 of 426. All products under Clamp
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K770118 | 1977-01-26 |
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 | Closed |
|---|---|---|---|---|---|
| 2018-05-04 | Class II | Other | Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm | 18 parts (10 parts quarantined) | 2020-04-27 |
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.