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.

Registry build 21.09.26
22manufacturers in China registered for this device type
216catalogue numbers in this listing

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.

Chinese manufacturers registered for FDA product code HRS
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

Regulatory record for Humeral Fixation Set
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

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 numbers for Humeral Fixation Set
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

Other products under the same FDA 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer