Brasseler USA
KM168-29-33S 3/32 X 9" DBL Troc
12manufacturers in China registered for this device type
89catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Aplus (Guangzhou) Medical Technology Company | Guangzhou | Guangdong | Contract manufacturer | 6 |
| 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 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Peter Brasseler Holdings, LLC |
|---|---|
| FDA product code | HTY |
| Device type | Pin, Fixation, Smooth |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Record published | 2023-12-16 |
| Record revised | 2025-02-06 (version 4) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5008007M0 | In distribution | |
| 5014408M0 | In distribution | |
| 5008780M0 | In distribution | |
| 5008015M0 | In distribution | |
| 5008779M0 | In distribution | |
| 5014416M0 | In distribution | |
| 5009190M0 | In distribution | |
| 5007973M0 | In distribution | |
| 5014406M0 | In distribution | |
| 5008776M0 | In distribution | |
| BR144170 | In distribution | |
| 5007975M0 | In distribution | |
| 5007978M0 | In distribution | |
| 5007972M0 | In distribution | |
| 5008009M0 | In distribution | |
| 5013768M0 | In distribution | |
| 5014424M0 | In distribution | |
| 5008931M0 | In distribution | |
| 5008006M0 | In distribution | |
| 5008012M0 | In distribution | |
| 5013087M0 | In distribution | |
| BR144140 | In distribution | |
| 5014404M0 | In distribution | |
| 5014415M0 | In distribution | |
| 5009189M0 | In distribution | |
| 5014418M0 | In distribution | |
| 5007976M0 | In distribution | |
| 5013770M0 | In distribution | |
| 5008003M0 | In distribution | |
| 5014414M0 | In distribution | |
| BR213527 | In distribution | |
| 5014405M0 | In distribution | |
| 5014420M0 | In distribution | |
| 5014400M0 | In distribution | |
| 5008895M0 | In distribution | |
| 5008002M0 | In distribution | |
| 5014402M0 | In distribution | |
| 5015239M0 | In distribution | |
| 5008005M0 | In distribution | |
| 5014412M0 | In distribution | |
| 5009188M0 | In distribution | |
| 5008778M0 | In distribution | |
| 5016178M0 | In distribution | |
| 5014421M0 | In distribution | |
| 5007971M0 | In distribution | |
| 5009187M0 | In distribution | |
| 5013085M0 | In distribution | |
| 5009160M0 | In distribution | |
| 5014425M0 | In distribution | |
| 5014426M0 | In distribution | |
| 5014410M0 | In distribution | |
| 5014403M0 | In distribution | |
| 5008010M0 | In distribution | |
| 5008777M0 | In distribution | |
| 5014413M0 | In distribution | |
| 5017909M0 | In distribution | |
| 5013769M0 | In distribution | |
| 5013322M0 | In distribution | |
| 5014409M0 | In distribution | |
| 5014419M0 | In distribution | |
| 5014407M0 | In distribution | |
| 5007981M0 | In distribution | |
| 5014422M0 | In distribution | |
| 5025109M0 | In distribution | |
| BR213524 | In distribution | |
| 5020122M0 | In distribution | |
| 5012152M0 | In distribution | |
| 5008016M0 | In distribution | |
| 5013086M0 | In distribution | |
| 5014411M0 | In distribution | |
| 5008008M0 | In distribution | |
| 5008014M0 | In distribution | |
| 5009186M0 | In distribution | |
| 5008004M0 | In distribution | |
| BR144110 | In distribution | |
| 5013088M0 | In distribution | |
| 5007980M0 | In distribution | |
| 5008013M0 | In distribution | |
| 5014399M0 | In distribution | |
| 5008011M0 | In distribution | |
| 5014401M0 | In distribution | |
| 5015238M0 | In distribution | |
| 5024320M0 | In distribution | |
| 5013321M0 | In distribution | |
| 5007974M0 | In distribution | |
| 5007977M0 | In distribution | |
| 5014423M0 | In distribution | |
| 5009159M0 | In distribution | |
| 5014417M0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rondo’ | Citieffe SRL | 265 |
| HNM Medical | HNM Stainless, LLC. | 232 |
| Kmedic | Teleflex Medical LLC | 227 |
| gSource | Gsource, LLC. | 221 |
| MicroAire® | Microaire Surgical Instruments LLC | 213 |
| Orthomed | Ortho-MED, Inc. | 163 |
| mahe medical GmbH | Mahe Intl., Inc. | 160 |
| Pin, Fixation, Smooth | Key Surgical, LLC | 134 |
| Pin, Fixation, Smooth | Stryker GmbH | 134 |
| Aptus | Medartis Inc. | 134 |
| Key Surgical K-Wires and Steinmann Pins | Key Surgical, LLC | 126 |
| PedFlex Flexible Nailing System | Orthopediatrics, Corp | 119 |
Showing 12 of 682. All products under Pin, Fixation, Smooth
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 | Closed |
|---|---|---|---|---|---|---|---|
| Brasseler U.S.A. Medical, LLC | UDI-DI | 2022-01-28 | Class II | Under Investigation by firm | One lot of product was distributed in unsealed packaging | 231 units | 2023-02-03 |
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.