Dhhs

Dhhs Helix Blade 100MM-STERILE

Registry build 21.09.26
2manufacturers in China registered for this device type
6catalogue numbers in this listing

Who Else Makes It

All of them in Shanghai. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code JDO
Manufacturer City Province Registered as Device types
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106

Record

Regulatory record for Dhhs
Listed by Synthes Gmbh, Switzerland
FDA product code JDO
Device type Device, Fixation, Proximal Femoral, Implant
Device class Class 2
Regulation 21 CFR 888.3030
Establishment Specification developer, Manufacturer, Exporter
510(k) K042895
Record published 2015-09-14
Record revised 2022-04-29 (version 4)

Specifications

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

Catalogue Numbers

Catalogue numbers for Dhhs
Catalogue number Size Status
282.238S In distribution
282.239S In distribution
282.243S In distribution
282.237S In distribution
282.248S In distribution
282.241S In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
BMP Compression HIP Screw Biomet Orthopedics 112
DHS Synthes Gmbh 93
THP™ Hip Fracture Plating System Biomet Orthopedics 74
Percutaneous Compression Plate (Pc.c.p) Orthofix SRL 69
Proform Hip System Globus Medical, Inc. 51
Conquest FN Smith & Nephew, Inc. 31
CHS Smith & Nephew, Inc. 26
Large Cannulated Screws Smith & Nephew, Inc. 22
TSP HIP FX Plating SYSTEM4.5MM Cortical NON – Locking Screw Biomet Orthopedics 13
TSP HIP FX Plating SYSTEM4.5MM Cortical Locking Screw Biomet Orthopedics 12
TSP HIP FX Plating SYSTEM7.5MM Telescoping LAG Screw Biomet Orthopedics 6
3P Hip System Orthopediatrics, Corp 5

Showing 12 of 112. All products under Device, Fixation, Proximal Femoral, Implant

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