Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Post
17manufacturers in China registered for this device type
36catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (4), Zhejiang (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| 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 Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 17. All 17 manufacturers in China registered for Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Record
| Listed by | Wright Medical Technology, Inc., United States |
|---|---|
| FDA product code | KTT |
| Device type | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K130044 |
| Record published | 2022-05-31 |
| Record revised | 2022-08-17 (version 5) |
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, manufacturing date |
| Sizes | Length 12 to 400 mm; height 1 to 10 mm; outer diameter 1.8 to 5 mm |
| Distribution end date | 2022-11-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EF001500 | In distribution | |
| EF002450 | Size: 2mm | In distribution |
| RR1001 | Size: 10mm | In distribution |
| RR1200PK | Multipack of 10 | In distribution |
| RR10P | Hole Qty: 1 | In distribution |
| RR20P | Hole Qty: 2 | In distribution |
| RR20PF | Hole Qty: 2 | In distribution |
| RR0080TR | Length 80 mm | In distribution |
| EF1650PK | Hole Qty: 6 | In distribution |
| RR7500 | Circular | In distribution |
| RR5035TN | Outer Diameter 5 mm | In distribution |
| RR18400 | Length 400 mm | In distribution |
| RR5050TN | Length 180 mm | In distribution |
| RR2000 | Length 20 mm | In distribution |
| RR1600 | Length 16 mm | In distribution |
| EF3005PK | Height 5 mm | In distribution |
| RR0400TR | Length 400 mm | In distribution |
| RR2501 | Height 2.5 mm | In distribution |
| RR30PF | Hole Qty: 3 | In distribution |
| RR180400 | Outer Diameter 1.8 mm | In distribution |
| RR3000 | Length 30 mm | In distribution |
| RR5300W | In distribution | |
| RR2501PK | Height 2.5 mm | In distribution |
| RR2401PK | Height 1 mm | In distribution |
| EF001650 | Hole Qty: 6 | In distribution |
| RR100PL | Hole Qty: 1 | In distribution |
| RR40PF | Hole Qty: 4 | In distribution |
| EF3010PK | Multipack of 3 | In distribution |
| RR2401 | Height 1 mm | In distribution |
| RR0300TR | Length 300 mm | In distribution |
| EF002500 | In distribution | |
| EF003700 | Withdrawn | |
| EF001600 | Withdrawn | |
| EF002550 | Withdrawn | |
| EF003005 | Height 5 mm | Withdrawn |
| EF003010 | Height 10 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Smart Correction | Wishbone Medical Inc. | 1,534 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Synthes Gmbh | 880 |
| LCP | Synthes Gmbh | 355 |
| Orthex External Fixation System | Orthopediatrics, Corp | 353 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Sterilmed, Inc. | 325 |
| CHS | Smith & Nephew, Inc. | 321 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Stryker Sustainability Solutions | 277 |
| Hoffmann | Stryker GmbH | 239 |
| Orthex | Orthopediatrics, Corp | 231 |
| Orthex | Vilex IN Tennessee, Inc. | 221 |
| Omega | Stryker GmbH | 212 |
| eZ-Fix | Orthopediatrics, Corp | 207 |
Showing 12 of 530. All products under Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162033 | 2017-03-06 |
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.