Equinoxe
Scapula Reconstruction System, Anterior Hook Plate, 6mm Hook, 4 hole, Right
22manufacturers in China registered for this device type
163catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 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 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Exactech, Inc., United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K093978 |
| Record published | 2015-10-30 |
| Record revised | 2024-02-19 (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 |
| Sizes | Outer diameter 2.8 to 7.5 mm; length 20 to 150 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 340-00-45 | 45mm | In distribution |
| 370-75-50 | Length 50 mm | In distribution |
| 342-65-35 | Length 35 mm | In distribution |
| 341-01-30 | In distribution | |
| 340-00-50 | 50mm | In distribution |
| 371-03-01 | Large | In distribution |
| 342-65-50 | Outer Diameter 6.5 mm | In distribution |
| 342-38-38 | Outer Diameter 3.8 mm | In distribution |
| 341-65-02 | Outer Diameter 5.5 mm | In distribution |
| 341-01-10 | In distribution | |
| 377-00-05 | In distribution | |
| 376-11-04 | In distribution | |
| 341-38-02 | Outer Diameter 3.3 mm | In distribution |
| 370-75-45 | Outer Diameter 7.5 mm | In distribution |
| 342-65-56 | Outer Diameter 6.5 mm | In distribution |
| 370-65-55 | Length 55 mm | In distribution |
| 370-03-115 | In distribution | |
| 341-12-39 | Outer Diameter 3.8 mm | In distribution |
| 340-01-03 | Left | In distribution |
| 370-03-85 | In distribution | |
| 370-14-85 | Length 85 mm | In distribution |
| 342-38-35 | Length 35 mm | In distribution |
| 370-04-85 | Length 85 mm | In distribution |
| 340-65-35 | Outer Diameter 6.5 mm | In distribution |
| 370-65-40 | Length 40 mm | In distribution |
| 342-65-47 | Length 47 mm | In distribution |
| 341-02-65 | Outer Diameter 5.5 mm | In distribution |
| 341-15-01 | In distribution | |
| 341-15-00 | In distribution | |
| 342-38-56 | Length 56 mm | In distribution |
| 340-65-50 | Length 50 mm | In distribution |
| 341-03-65 | Outer Diameter 6.5 mm | In distribution |
| 340-00-55 | 55mm | In distribution |
| 370-75-55 | Outer Diameter 7.5 mm | In distribution |
| 342-65-53 | Length 53 mm | In distribution |
| 342-38-50 | Outer Diameter 3.8 mm | In distribution |
| 341-01-01 | In distribution | |
| 340-02-01 | 80mm | In distribution |
| 341-01-38 | In distribution | |
| 340-02-02 | Right | In distribution |
| 341-01-41 | In distribution | |
| 341-04-38 | In distribution | |
| 340-40-20 | Length 20 mm | In distribution |
| 340-38-20 | Outer Diameter 3.8 mm | In distribution |
| 377-00-07 | In distribution | |
| 370-13-150 | In distribution | |
| 341-02-21 | In distribution | |
| 340-40-29 | Outer Diameter 3.8 mm | In distribution |
| 340-38-56 | Outer Diameter 3.8 mm | In distribution |
| 370-75-40 | Outer Diameter 7.5 mm | In distribution |
| 376-01-04 | In distribution | |
| 341-02-23 | In distribution | |
| 376-02-08 | In distribution | |
| 370-12-85 | In distribution | |
| 340-38-38 | Outer Diameter 3.8 mm | In distribution |
| 341-01-20 | In distribution | |
| 340-41-20 | Outer Diameter 3.8 mm | In distribution |
| 370-65-45 | Outer Diameter 7.5 mm | In distribution |
| 340-40-23 | Outer Diameter 3.8 mm | In distribution |
| 342-65-41 | Length 41 mm | In distribution |
| 342-65-44 | Outer Diameter 6.5 mm | In distribution |
| 340-38-35 | Length 35 mm | In distribution |
| 341-01-33 | Outer Diameter 3.3 mm | In distribution |
| 370-14-115 | Length 115 mm | In distribution |
| 340-65-53 | Outer Diameter 6.5 mm | In distribution |
| 341-03-38 | Outer Diameter 3.3 mm | In distribution |
| 341-10-38 | In distribution | |
| 370-12-150 | In distribution | |
| 370-01-13 | In distribution | |
| 340-00-00 | In distribution | |
| 340-38-47 | Length 47 mm | In distribution |
| 376-02-06 | In distribution | |
| 340-40-32 | Length 32 mm | In distribution |
| 342-65-38 | Outer Diameter 6.5 mm | In distribution |
| 370-02-85 | In distribution | |
| 340-41-23 | Length 23 mm | In distribution |
| 341-12-65 | Outer Diameter 6.5 mm | In distribution |
| 340-41-29 | Length 29 mm | In distribution |
| 376-02-04 | In distribution | |
| 342-38-29 | Length 29 mm | In distribution |
| 341-15-38 | Outer Diameter 3.8 mm | In distribution |
| 341-01-21 | In distribution | |
| 341-01-38 | In distribution | |
| 340-38-50 | Outer Diameter 3.8 mm | In distribution |
| 342-38-47 | Length 47 mm | In distribution |
| 341-12-38 | Outer Diameter 3.8 mm | In distribution |
| 340-00-30 | 30mm | In distribution |
| 341-01-28 | Outer Diameter 2.8 mm | In distribution |
| 340-40-26 | Length 26 mm | In distribution |
| 340-65-41 | Outer Diameter 6.5 mm | In distribution |
| 341-12-04 | Outer Diameter 6.5 mm | In distribution |
| 371-02-01 | In distribution | |
| 341-01-65 | In distribution | |
| 342-38-53 | Length 53 mm | In distribution |
| 340-41-32 | Outer Diameter 3.8 mm | In distribution |
| 371-02-00 | In distribution | |
| 371-03-00 | Large | In distribution |
| 340-65-47 | Outer Diameter 6.5 mm | In distribution |
| 341-02-38 | Outer Diameter 3.3 mm | In distribution |
| 340-41-26 | Outer Diameter 3.8 mm | In distribution |
| 370-13-115 | In distribution | |
| 342-38-41 | Length 41 mm | In distribution |
| 341-12-03 | Outer Diameter 6.5 mm | In distribution |
| 376-03-05 | In distribution | |
| 342-38-26 | Outer Diameter 3.8 mm | In distribution |
| 342-38-23 | Length 23 mm | In distribution |
| 371-04-00 | Small | In distribution |
| 340-38-23 | Length 23 mm | In distribution |
| 370-04-150 | Length 150 mm | In distribution |
| 370-65-35 | Length 35 mm | In distribution |
| 341-12-01 | In distribution | |
| 340-00-25 | 25mm | In distribution |
| 341-01-72 | In distribution | |
| 342-38-32 | Outer Diameter 3.8 mm | In distribution |
| 370-13-85 | In distribution | |
| 341-12-02 | In distribution | |
| 341-15-65 | Outer Diameter 6.5 mm | In distribution |
| 376-12-06 | In distribution | |
| 340-38-29 | Length 29 mm | In distribution |
| 377-00-04 | In distribution | |
| 370-04-115 | Length 115 mm | In distribution |
| 340-65-44 | Length 44 mm | In distribution |
| 376-12-08 | In distribution | |
| 370-14-150 | Length 150 mm | In distribution |
| 342-38-44 | Outer Diameter 3.8 mm | In distribution |
| 341-02-10 | In distribution | |
| 340-01-02 | 115mm | In distribution |
| 340-00-40 | 40mm | In distribution |
| 376-13-07 | In distribution | |
| 340-00-35 | 35mm | In distribution |
| 340-65-56 | Length 56 mm | In distribution |
| 371-04-01 | Small | In distribution |
| 341-01-23 | In distribution | |
| 376-12-10 | In distribution | |
| 340-02-03 | 150mm | In distribution |
| 370-02-150 | In distribution | |
| 370-02-115 | In distribution | |
| 340-38-53 | Length 53 mm | In distribution |
| 370-12-115 | In distribution | |
| 370-65-50 | Length 50 mm | In distribution |
| 341-01-70 | In distribution | |
| 340-38-41 | Length 41 mm | In distribution |
| 342-65-32 | Outer Diameter 6.5 mm | In distribution |
| 341-02-30 | In distribution | |
| 341-01-71 | In distribution | |
| 341-02-28 | Outer Diameter 2.8 mm | In distribution |
| 340-38-44 | Outer Diameter 3.8 mm | In distribution |
| 340-65-38 | Length 38 mm | In distribution |
| 342-38-20 | Outer Diameter 3.8 mm | In distribution |
| 341-01-55 | Outer Diameter 5.5 mm | In distribution |
| 341-01-40 | In distribution | |
| 370-01-12 | In distribution | |
| 341-12-28 | Outer Diameter 2.8 mm | In distribution |
| 341-12-55 | Outer Diameter 5.5 mm | In distribution |
| 340-65-32 | Length 32 mm | In distribution |
| 370-75-35 | Length 35 mm | In distribution |
| 376-12-04 | In distribution | |
| 340-01-01 | Left | In distribution |
| 370-03-150 | In distribution | |
| 376-02-10 | In distribution | |
| 340-38-26 | Outer Diameter 3.8 mm | In distribution |
| 341-12-33 | Outer Diameter 3.3 mm | In distribution |
| 340-38-32 | Outer Diameter 3.8 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243275 | 2025-06-26 |
| K223933 | 2023-09-25 |
| K093978 | 2010-05-11 |
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.