DJO Surgical
SPECIAL, ALTIVATE REVERSE HUMERAL BROACH, 16 X 175mm, MOD.
12manufacturers in China registered for this device type
132catalogue numbers in this listing
1recall
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 | Encore Medical, L.P., United States |
|---|---|
| FDA product code | HTQ |
| Device type | Broach |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K190290 |
| Record published | 2023-09-15 |
| Record revised | 2023-06-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S-201677 | In distribution | |
| 803-21-314 | In distribution | |
| 803-04-071 | In distribution | |
| 803-03-212 | In distribution | |
| 804-06-120 | In distribution | |
| 804-06-118 | In distribution | |
| S-201681 | In distribution | |
| 803-08-207 | In distribution | |
| 803-08-201 | In distribution | |
| 414815 | In distribution | |
| S-201679 | In distribution | |
| 804-06-052 | In distribution | |
| 803-21-215 | In distribution | |
| 803-04-063 | In distribution | |
| 803-08-203 | In distribution | |
| 803-08-103 | In distribution | |
| 803-08-111 | In distribution | |
| 803-03-063 | In distribution | |
| 414863 | In distribution | |
| 803-03-206 | In distribution | |
| 803-21-310 | In distribution | |
| 804-06-108 | In distribution | |
| 803-03-208 | In distribution | |
| 803-03-205 | In distribution | |
| 803-08-110 | In distribution | |
| 803-08-206 | In distribution | |
| 801-01-014 | In distribution | |
| 414866 | In distribution | |
| 414812 | In distribution | |
| 803-04-066 | In distribution | |
| S-201676 | In distribution | |
| 803-08-211 | In distribution | |
| 803-21-311 | In distribution | |
| 803-21-210 | In distribution | |
| 803-04-061 | In distribution | |
| 803-08-102 | In distribution | |
| 803-03-215 | In distribution | |
| 803-21-205 | In distribution | |
| 803-03-207 | In distribution | |
| 803-08-105 | In distribution | |
| 803-21-317 | In distribution | |
| 803-21-212 | In distribution | |
| 803-04-070 | In distribution | |
| 804-06-114 | In distribution | |
| 801-01-179 | In distribution | |
| 804-06-048 | In distribution | |
| 803-08-107 | In distribution | |
| 803-03-210 | In distribution | |
| 803-08-101 | In distribution | |
| 803-06-004 | In distribution | |
| 803-21-304 | In distribution | |
| 803-21-315 | In distribution | |
| 803-21-219 | In distribution | |
| 803-08-212 | In distribution | |
| 803-21-308 | In distribution | |
| 804-06-050 | In distribution | |
| 803-21-209 | In distribution | |
| 414813 | In distribution | |
| 803-03-209 | In distribution | |
| 414820 | In distribution | |
| 803-03-066 | In distribution | |
| 804-06-112 | In distribution | |
| 414865 | In distribution | |
| 804-06-116 | In distribution | |
| 414810 | In distribution | |
| 803-03-216 | In distribution | |
| 414861 | In distribution | |
| 803-21-306 | In distribution | |
| 804-06-106 | In distribution | |
| 801-04-025 | In distribution | |
| 803-03-204 | In distribution | |
| 803-08-100 | In distribution | |
| 414862 | In distribution | |
| 803-21-204 | In distribution | |
| 414823 | In distribution | |
| 414822 | In distribution | |
| 803-04-069 | In distribution | |
| 803-21-213 | In distribution | |
| 803-21-316 | In distribution | |
| 414817 | In distribution | |
| 803-08-202 | In distribution | |
| 414821 | In distribution | |
| 803-03-219 | In distribution | |
| 803-21-217 | In distribution | |
| 803-21-305 | In distribution | |
| 803-21-207 | In distribution | |
| S-201680 | In distribution | |
| 803-03-214 | In distribution | |
| 803-08-208 | In distribution | |
| 804-06-110 | In distribution | |
| 803-21-208 | In distribution | |
| 803-08-204 | In distribution | |
| 803-08-109 | In distribution | |
| 803-21-216 | In distribution | |
| 803-21-313 | In distribution | |
| 803-21-309 | In distribution | |
| 803-08-106 | In distribution | |
| 414931 | In distribution | |
| 803-21-319 | In distribution | |
| 803-08-210 | In distribution | |
| 803-61-033 | In distribution | |
| 414801 | In distribution | |
| 414868 | In distribution | |
| 803-04-062 | In distribution | |
| 414818 | In distribution | |
| 803-08-112 | In distribution | |
| 801-01-178 | In distribution | |
| 803-08-108 | In distribution | |
| 803-08-1001 | In distribution | |
| 803-08-209 | In distribution | |
| S-201678 | In distribution | |
| 803-21-214 | In distribution | |
| 414814 | In distribution | |
| 803-21-312 | In distribution | |
| 803-04-058 | In distribution | |
| 803-08-104 | In distribution | |
| 414816 | In distribution | |
| 803-08-034 | In distribution | |
| 803-08-205 | In distribution | |
| 803-03-221 | In distribution | |
| 803-03-217 | In distribution | |
| 414811 | In distribution | |
| 803-04-106 | In distribution | |
| 803-21-211 | In distribution | |
| 803-21-206 | In distribution | |
| 804-00-093 | In distribution | |
| 414864 | In distribution | |
| 803-03-211 | In distribution | |
| 803-03-213 | In distribution | |
| 804-06-042 | In distribution | |
| 414867 | In distribution | |
| 803-21-307 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Intervertebral Disc Preparation Instruments | Alphatec Spine, Inc. | 119 |
| DJO Surgical | DJO, LLC | 89 |
| 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
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-04-21 | Not classified | Process control | Strike plate may dislodge from the broach stem handle during impaction of the device. | 15 units | 2012-04-06 |
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.