Humeral Fixation Set
216 catalogue numbers from Drill, 3.5mm x 50mm, listed by Skeletal Dynamics L.L.C., under Plate, Fixation, Bone. 22 manufacturers in China are registered for 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 | Skeletal Dynamics L.L.C. |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K200367 |
| Record published | 2023-12-22 |
| Record revised | 2025-02-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Sizes | Outer diameter 4 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Drill, 3.5mm x 50mm | In distribution | |
| Screw, FreeFix™ Compression, 3.5mm x 18mm, Ti | In distribution | |
| Screw, FreeFix™ Locking, 3.5mm x 24mm, Ti | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 50mm, Ti | In distribution | |
| Screw, FreeFix™ Locking, 3.5mm x 10mm, Ti | In distribution | |
| Screw, FreeFix™ Compression, 4.5mm x 30mm, Ti | In distribution | |
| Screw, FreeFix™ Compression, 3.5mm x 36mm, Ti | In distribution | |
| FreeFix™, Distal Humerus Plate, Medial Direct, 6 Hole, Left | In distribution | |
| Drill, 3.2mm / 4.5mm, Reusable | In distribution | |
| FreeFix™, Distal Humerus Plate, Lateral Capitellar, 3 Hole, Left | In distribution | |
| Screw, FreeFix™ Locking, 4.5mm x 28mm, Ti | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 65mm Cannulated, CoCr | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 20mm, Ti | In distribution | |
| Drill, 2.5mm x 50mm, Reusable | In distribution | |
| Screw, FreeFix™ Compression, 4.5mm x 24mm, Ti | In distribution | |
| Humeral Fixation Set Tray B | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 42mm, Ti | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 46mm, Ti | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 48mm, Ti | In distribution | |
| Screw, FreeFix™ Compression, 4.5mm x 40mm, Ti | In distribution | |
| Drill, 2.7mm x 50mm, Reusable | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 46mm, Ti | In distribution | |
| Screw, FreeFix™ Compression, 3.5mm x 30mm, Ti | In distribution | |
| Screw, FreeFix™ Locking, 4.5mm x 18mm, Ti | In distribution | |
| K-Wire, Single Diamond, 1.5mm x 127mm | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 46mm Cannulated, CoCr | In distribution | |
| Humeral Fixation System B | In distribution | |
| Thread-in Off Axis Drill Guide, FreeFix™ 4.5mm | In distribution | |
| Drill, 2.5mm x 50mm | In distribution | |
| Threaded Peg, Fluted, Locking, 2.3mm x 26mm, Ti | In distribution | |
| Humeral Fixation Set Tray B, Base | In distribution | |
| Screw, FreeFix™ Compression, 3.5mm x 20mm, Ti | In distribution | |
| Distal Trochlea Compression Screw, 3.5mm x 25mm, Ti | In distribution | |
| FreeFix™, Distal Humerus Plate, Lateral Capitellar, 9 Hole, Left | In distribution | |
| Threaded Peg, Fluted, Locking, 2.3mm x 20mm, Ti | In distribution | |
| Threaded Peg, Fluted, Locking, 2.3mm x 12mm, Ti | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 30mm, Ti | In distribution | |
| Drill, Cannulated, PLS, 2.4mm x 40mm, Reusable | In distribution | |
| Screw, FreeFix™ Compression, 4.5mm x 28mm, Ti | In distribution | |
| Screw, FreeFix™ Locking, 3.5mm x 34mm, Ti | In distribution | |
| K-Wire, Standard Tip, HPS PLS, 1.1 mm x 229 mm | In distribution | |
| Humeral Fixation System A | In distribution | |
| Screw, FreeFix™ Compression, 3.5mm x 32mm, Ti | In distribution | |
| FreeFix™, Distal Humerus Plate, Lateral Direct, 3 Hole, Right | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 42mm, Ti | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 50mm Cannulated, CoCr | In distribution | |
| AIMing Guides, 2.0mm Snap Fit | In distribution | |
| FreeFix™, Distal Humerus Plate, Medial Direct, 8 Hole, Left | In distribution | |
| Threaded Peg, Fluted, Locking, 2.3mm x 16mm, Ti | In distribution | |
| Screw, FreeFix™ Locking, 4.5mm x 22mm, Ti | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 44mm, Ti | In distribution | |
| Humeral Fixation Set Tray A, Base | In distribution | |
| Threaded Peg, Fluted, Locking, 2.3mm x 28mm, Ti | In distribution | |
| Drill, 2.7mm x 50mm | In distribution | |
| Threaded Peg, Fluted, Locking, 2.3mm x 36mm, Ti | In distribution | |
| Off Axis Drill Guide, FreeFix™ 4.5mm | In distribution | |
| Off Axis Drill Guide, FreeFix™ 3.5mm | In distribution | |
| Humeral Fixation Set Tray A, PROTEAN Screw Caddy | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 55mm Cannulated, CoCr | In distribution | |
| FreeFix™, Distal Humerus Plate, Lateral Direct, 5 Hole, Right | In distribution | |
| Threaded Peg, Fluted, Locking, 2.3mm x 14mm, Ti | In distribution | |
| Distal Humerus Plate, Supracondylar, 6 Hole, Right | In distribution | |
| Drill, 3.5mm x 50mm, Reusable | In distribution | |
| Screw, FreeFix™ Compression, 4.5mm x 36mm, Ti | In distribution | |
| Screw, FreeFix™ Compression, 4.5mm x 32mm, Ti | In distribution | |
| FreeFix™, Distal Humerus Plate, Medial Direct, 3 Hole, Right | In distribution | |
| Screw, FreeFix™ Compression, 4.5mm x 14mm, Ti | In distribution | |
| FreeFix™, Distal Humerus Plate, Medial Direct, 5 Hole, Right | In distribution | |
| Thread-In Drill Guide, FreeFix™, 2.0mm K-Wire | In distribution | |
| Screw, FreeFix™ Compression, 3.5mm x 10mm, Ti | In distribution | |
| FreeFix™, Distal Humerus Plate, Lateral Capitellar, 7 Hole, Right | In distribution | |
| Screw, FreeFix™ Compression, 4.5mm x 26mm, Ti | In distribution | |
| FreeFix™, Distal Humerus Plate, Lateral Helical, 3 Hole, Right | In distribution | |
| Thread-in Drill Guide, FreeFix™, 3.5mm | In distribution | |
| FreeFix™, Distal Humerus Plate, Lateral Helical, 9 Hole, Right | In distribution | |
| HPS PLS K-Wire Guide | In distribution | |
| Drill, Cannulated, 4.0mm x 20mm, Reusable | In distribution | |
| K-Wire, Standard Diamond Tip with Stop, 2.0 mm x 152 mm | In distribution | |
| Humeral Fixation Set Tray A, Top Insert | In distribution | |
| Threaded Peg, Fluted, Locking, 2.3mm x 40mm, Ti | In distribution | |
| TiBeam™, Trochlea Compression Screw, Insertion Tool | In distribution | |
| Screw, FreeFix™ Locking, 3.5mm x 42mm, Ti | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 44mm, Ti | In distribution | |
| Humeral Fixation Set Tray B, Middle Insert | In distribution | |
| Distal Humerus Plate, Supracondylar, 6 Hole, Left | In distribution | |
| FreeFix™, Distal Humerus Plate, Medial Direct, 5 Hole, Left | In distribution | |
| FreeFix™, Distal Humerus Plate, Lateral Helical, 7 Hole, Left | In distribution | |
| Screw, FreeFix™ Compression, 3.5mm x 26mm, Ti | In distribution | |
| FreeFix™, Distal Humerus Plate, Lateral Capitellar, 5 Hole, Left | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 44mm, Ti | In distribution | |
| Distal Humerus Plate, Supracondylar, 8 Hole, Right | In distribution | |
| Countersink, 6.5mm, Reusable | In distribution | |
| Screw, FreeFix™ Locking, 4.5mm x 14mm, Ti | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 12mm, Ti | In distribution | |
| Threaded Peg, Fluted, Locking, 2.3mm x 32mm, Ti | In distribution | |
| FreeFix™, Distal Humerus Plate, Lateral Helical, 9 Hole, Left | In distribution | |
| Thread-in Off Axis Drill Guide, FreeFix™ 3.5mm | In distribution | |
| Screw, FreeFix™ Locking, 3.5mm x 36mm, Ti | In distribution | |
| Large Reduction Forceps, Speed Lock | In distribution | |
| Screw, FreeFix™ Locking, 3.5mm x 28mm, Ti | In distribution | |
| FreeFix™, Distal Humerus Plate, Lateral Helical, 5 Hole, Left | In distribution | |
| Humeral Fixation Set Tray A, Middle Insert | In distribution | |
| FreeFix™, Distal Humerus Plate, Lateral Helical, 3 Hole, Left | In distribution | |
| Screw, FreeFix™ Locking, 4.5mm x 34mm, Ti | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 55mm, Ti | In distribution | |
| FreeFix™, Distal Humerus Plate, Lateral Direct, 3 Hole, Left | In distribution | |
| FreeFix™, Distal Humerus Plate, Lateral Helical, 5 Hole, Right | In distribution | |
| Thread-in Drill Guide, 2.0mm XL | In distribution | |
| Drill, Cannulated, PLS, 2.4mm x 40mm | In distribution | |
| FreeFix™, Distal Humerus Plate, Lateral Capitellar, 3 Hole, Right | In distribution | |
| Screw, FreeFix™ Locking, 3.5mm x 32mm, Ti | In distribution | |
| K-Wire, Single Diamond Trocar, 1.5 mm x 229 mm | In distribution | |
| Screw, FreeFix™ Locking, 4.5mm x 24mm, Ti | In distribution | |
| Screw, FreeFix™ Locking, 4.5mm x 26mm, Ti | In distribution | |
| Screw, FreeFix™ Compression, 4.5mm x 38mm, Ti | In distribution | |
| Humeral Fixation Set Tray A | In distribution | |
| Screw, FreeFix™ Compression, 4.5mm x 18mm, Ti | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 70mm, Ti | In distribution | |
| Screw, FreeFix™ Compression, 3.5mm x 16mm, Ti | In distribution | |
| FreeFix™, Distal Humerus Plate, Medial Direct, 3 Hole, Left | In distribution | |
| Screw, FreeFix™ Compression, 3.5mm x 44mm, Ti | In distribution | |
| Screw, FreeFix™ Compression, 4.5mm x 34mm, Ti | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 22mm, Ti | In distribution | |
| FreeFix™, Distal Humerus Plate, Medial Direct, 6 Hole, Right | In distribution | |
| K-Wire, Standard Tip, HPS PLS, 1.1 mm x 152 mm | In distribution | |
| Forceps, Bone Holding Large, Speed Lock | In distribution | |
| Screw, FreeFix™ Compression, 3.5mm x 22mm, Ti | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 65mm, Ti | In distribution | |
| Cannulated Depth Gauge, Polyaxial Locking Screw, 3.0mm x 70mm | In distribution | |
| Screw, FreeFix™ Locking, 4.5mm x 32mm, Ti | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 70mm Cannulated, CoCr | In distribution | |
| Threaded Peg, Fluted, Locking, 2.3mm x 30mm, Ti | In distribution | |
| Drill, 3.2mm x 50mm, Reusable | In distribution | |
| Distal Trochlea Compression Screw, 3.5mm x 30mm, Ti | In distribution | |
| Drill, 3.2mm x 50mm | In distribution | |
| FreeFix™, Distal Humerus Plate, Lateral Capitellar, 7 Hole, Left | In distribution | |
| Drill Guide, FreeFix™, HPS | In distribution | |
| Drill, Cannulated, 4.0mm x 20mm | Outer Diameter 4 mm | In distribution |
| Screw, FreeFix™ Compression, 3.5mm x 38mm, Ti | In distribution | |
| Screw, FreeFix™ Locking, 3.5mm x 18mm, Ti | In distribution | |
| Screw, FreeFix™ Locking, 3.5mm x 20mm, Ti | In distribution | |
| Screw, FreeFix™ Compression, 3.5mm x 12mm, Ti | In distribution | |
| FreeFix™, Distal Humerus Plate, Lateral Capitellar, 9 Hole, Right | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 55mm, Ti | In distribution | |
| Screw, FreeFix™ Compression, 4.5mm x 20mm, Ti | In distribution | |
| Screw, FreeFix™ Compression, 3.5mm x 24mm, Ti | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 44mm, Ti | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 12mm Cannulated, CoCr | In distribution | |
| Screw, FreeFix™ Compression, 3.5mm x 28mm, Ti | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 48mm, Ti | In distribution | |
| Threaded Peg, Fluted, Locking, 2.3mm x 24mm, Ti | In distribution | |
| Screw, FreeFix™ Locking, 3.5mm x 12mm, Ti | In distribution | |
| Depth Gauge, HPS | In distribution | |
| FreeFix™, Distal Humerus Plate, Lateral Capitellar, 5 Hole, Right | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 42mm, Ti | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 48mm, Ti | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 42mm, Ti | In distribution | |
| Screw, FreeFix™ Locking, 4.5mm x 16mm, Ti | In distribution | |
| Drill, 2.7mm x 80mm, Reusable | In distribution | |
| Humeral Fixation Set Tray B, Bottom Insert | In distribution | |
| Reduction Forceps, Long Ratcheting | In distribution | |
| Distal Trochlea Compression Screw, 3.5mm x 35mm, Ti | In distribution | |
| Humeral Fixation Set Tray B, Top Insert | In distribution | |
| Distal Trochlea Compression Screw, 3.5mm x 20mm, Ti | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 46mm, Ti | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 48mm, Ti | In distribution | |
| Screw, FreeFix™ Locking, 3.5mm x 14mm, Ti | In distribution | |
| Humeral Fixation Set Tray B, Lid | In distribution | |
| TiBeam™, Trochlea Compression Screw, Removal Tool | In distribution | |
| Screw, FreeFix™ Locking, 3.5mm x 30mm, Ti | In distribution | |
| FreeFix™, Distal Humerus Plate, Medial Direct, 8 Hole, Right | In distribution | |
| Distal Humerus Plate, Supracondylar, 8 Hole, Left | In distribution | |
| Screw, FreeFix™ Compression, 4.5mm x 22mm, Ti | In distribution | |
| Screw, FreeFix™ Compression, 3.5mm x 40mm, Ti | In distribution | |
| Screw, FreeFix™ Locking, 3.5mm x 16mm, Ti | In distribution | |
| Screw, FreeFix™ Locking, 4.5mm x 30mm, Ti | In distribution | |
| Midshaft Humerus Plate, Broad 11 Hole | In distribution | |
| TiBeam™, Trochlea Compression Screw, Male, 60mm | In distribution | |
| Humeral Fixation Set Tray A, Distal Humerus Screw Caddy | In distribution | |
| Threaded Peg, Fluted, Locking, 2.3mm x 22mm, Ti | In distribution | |
| Screw, FreeFix™ Locking, 3.5mm x 40mm, Ti | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 14mm Cannulated, CoCr | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 18mm Cannulated, CoCr | In distribution | |
| K-Wire, Single Diamond, 2.0 mm x 152 mm | In distribution | |
| Drill Guide, FreeFix™, HPS | In distribution | |
| Drill, 2.0mm x 80mm, Reusable | In distribution | |
| Humeral Fixation Set Tray A, Midshaft Humerus Screw Caddy | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 10mm Cannulated, CoCr | In distribution | |
| Tissue Protector / Drill Guide, Dual Sided, 2.7mm x 3.5mm | In distribution | |
| Thread-In Drill Guide, FreeFix™, 1.6mm K-Wire | In distribution | |
| FreeFix™, Distal Humerus Plate, Lateral Helical, 7 Hole, Right | In distribution | |
| Distal Trochlea Compression Screw, 3.5mm x 60mm, Ti | In distribution | |
| Screw, FreeFix™ Compression, 3.5mm x 34mm, Ti | In distribution | |
| Screw, FreeFix™ Locking, 3.5mm x 26mm, Ti | In distribution | |
| Smooth Peg, Locking, 2.7mm x 10mm, Ti | In distribution | |
| Threaded Peg, Fluted, Locking, 2.3mm x 10mm, Ti | In distribution | |
| Screw, FreeFix™ Locking, 3.5mm x 44mm, Ti | In distribution | |
| Screw, FreeFix™ Compression, 3.5mm x 14mm, Ti | In distribution | |
| Drill, Cannulated, 3.7mm x 80mm, Reusable | In distribution | |
| FreeFix™, Distal Humerus Plate, Lateral Direct, 5 Hole, Left | In distribution | |
| Screw, FreeFix™ Compression, 3.5mm x 42mm, Ti | In distribution | |
| Screw, FreeFix™ Compression, 4.5mm x 16mm, Ti | In distribution | |
| Humeral Fixation Set Tray A, Lid | In distribution | |
| Tap, 4.5mm x 140mm | In distribution | |
| Threaded Peg, Fluted, Locking, 2.3mm x 18mm, Ti | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 36mm, Ti | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 34mm, Ti | In distribution | |
| Midshaft Humerus Plate, Broad 7 Hole | In distribution | |
| Screw, FreeFix™ Locking, 3.5mm x 38mm, Ti | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 46mm, Ti | In distribution | |
| Screw, FreeFix™ Locking, 3.5mm x 22mm, Ti | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 16mm Cannulated, CoCr | In distribution | |
| Tap, 3.5mm x 140mm | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 40mm, Ti | In distribution | |
| Screw, FreeFix™ Locking, 4.5mm x 20mm, Ti | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 34mm, Ti | Outer Diameter 4 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
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.