HemiCAP®
15mm Articular Comp 2.5mm x 4.5mm MTP
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Guangdong (1). 2 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 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
Record
| Listed by | Arthrosurface, Inc., United States |
|---|---|
| FDA product code | HWD |
| Device type | Starter, Bone Screw |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K131377 |
| Record published | 2015-09-15 |
| Record revised | 2022-02-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 15 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9152-2545-A | Outer Diameter 15 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Power Dental USA | Power Dental U.S.A. Inc. | 64 |
| Kompressor™ Compression Screw System | Ascension Orthopedics, Inc. | 11 |
| Mariner | Seaspine Orthopedics Corporation | 8 |
| CosmoLock Pedicle Screw System | Kalitec Direct, LLC | 6 |
| Slimplicity Anterior Cervical Plate System | Precision Spine, Inc. | 5 |
| Inbone | Wright Medical Technology, Inc. | 5 |
| Universal2 Total Wrist Implant System | Smith & Nephew, Inc. | 5 |
| Universal 2™ Total Wrist Implant System | Ascension Orthopedics, Inc. | 5 |
| Countersink | Biomet Orthopedics | 5 |
| AMP-LTX | Alphatec Spine, Inc. | 4 |
| Tibiaxys® | Newdeal Sas | 3 |
| Link Instruments – Fixation instruments | Waldemar Link GmbH & Co. KG | 3 |
Showing 12 of 90. All products under Starter, Bone Screw
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.