DJO Surgical
Broach, HUM. Diamondtooth SIZE16 Foundation Shoulder
12manufacturers in China registered for this device type
89catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (2), Guangdong (2). 6 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Changzhou Master Precision Tool Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Changzhou Xietong Industries Co., Ltd. | Changzhou | Jiangsu | Exporter | 11 |
| Changzhou Centrau Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
Record
| Listed by | DJO, LLC, United States |
|---|---|
| FDA product code | HTQ |
| Device type | Broach |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-05-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 803-04-007 | In distribution | |
| 803-04-101 | In distribution | |
| 803-04-105 | In distribution | |
| 803-00-111 | In distribution | |
| 803-99-016 | In distribution | |
| 804-00-096 | In distribution | |
| 803-04-053 | In distribution | |
| 803-03-064 | In distribution | |
| 803-04-059 | In distribution | |
| 803-04-099 | In distribution | |
| 803-00-113 | In distribution | |
| 803-04-093 | In distribution | |
| 804-05-108 | In distribution | |
| 803-04-012 | In distribution | |
| 803-04-011 | In distribution | |
| 803-04-003 | In distribution | |
| 803-04-097 | In distribution | |
| 803-04-005 | In distribution | |
| 803-04-064 | In distribution | |
| 803-04-047 | In distribution | |
| 803-04-068 | In distribution | |
| 804-05-110 | In distribution | |
| 803-04-009 | In distribution | |
| 804-00-092 | In distribution | |
| 804-02-009 | In distribution | |
| 803-04-010 | In distribution | |
| 803-04-090 | In distribution | |
| 803-00-115 | In distribution | |
| 803-03-070 | In distribution | |
| 804-00-091 | In distribution | |
| 803-04-098 | In distribution | |
| 803-04-004 | In distribution | |
| 803-03-073 | In distribution | |
| 804-02-006 | In distribution | |
| 803-03-062 | In distribution | |
| 803-03-074 | In distribution | |
| 803-03-072 | In distribution | |
| 803-03-071 | In distribution | |
| 804-02-010 | In distribution | |
| 804-00-094 | In distribution | |
| 803-00-109 | In distribution | |
| 803-04-046 | In distribution | |
| 804-05-114 | In distribution | |
| 803-00-110 | In distribution | |
| 803-04-100 | In distribution | |
| 803-00-112 | In distribution | |
| 803-04-095 | In distribution | |
| 803-03-068 | In distribution | |
| 803-03-060 | In distribution | |
| 803-00-120 | In distribution | |
| 804-02-018 | In distribution | |
| 804-02-019 | In distribution | |
| 804-00-180 | In distribution | |
| 803-04-103 | In distribution | |
| 803-03-075 | In distribution | |
| 803-04-060 | In distribution | |
| 803-04-006 | In distribution | |
| 803-04-091 | In distribution | |
| 803-04-092 | In distribution | |
| 803-00-116 | In distribution | |
| 803-04-052 | In distribution | |
| 803-03-065 | In distribution | |
| 804-02-017 | In distribution | |
| 804-02-016 | In distribution | |
| 804-05-007 | In distribution | |
| 804-02-007 | In distribution | |
| 803-03-069 | In distribution | |
| 803-04-001 | In distribution | |
| 803-04-094 | In distribution | |
| 803-99-002 | In distribution | |
| 803-04-096 | In distribution | |
| 803-61-089 | In distribution | |
| 804-05-112 | In distribution | |
| 804-05-116 | In distribution | |
| 803-04-067 | In distribution | |
| 804-00-095 | In distribution | |
| 803-00-108 | In distribution | |
| 803-04-072 | In distribution | |
| 804-00-140 | In distribution | |
| 803-04-008 | In distribution | |
| 803-04-102 | In distribution | |
| 803-03-067 | In distribution | |
| 804-00-009 | In distribution | |
| 804-05-106 | In distribution | |
| 803-61-061 | In distribution | |
| 804-02-008 | In distribution | |
| 803-03-061 | In distribution | |
| 803-04-104 | In distribution | |
| 803-04-002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DJO Surgical | Encore Medical, L.P. | 132 |
| Intervertebral Disc Preparation Instruments | Alphatec Spine, Inc. | 119 |
| iNSitu™ Hip System | Nextstep Arthropedix | 84 |
| OrthoMedFlex | Orthomedflex LLC | 63 |
| Anthology | Smith & Nephew, Inc. | 56 |
| LinkBio Instrument | Link BIO Corp | 53 |
| Profemur® | Microport Orthopedics Inc. | 47 |
| Calix Spinal Implant System | Xtant Medical Holdings, Inc. | 40 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 39 |
| Polar | Smith & Nephew, Inc. | 36 |
| Integra® | Ascension Orthopedics, Inc. | 36 |
| Plif | Depuy Spine, Inc. | 35 |
Showing 12 of 216. All products under Broach
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.