DJO Surgical
Special, Altivate Anatomic Ante/Retro-Version Guide, Size 42
53manufacturers in China registered for this device type
347catalogue numbers in this listing
6recalls on this code
Who Else Makes It
Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument
Record
| Listed by | Encore Medical, L.P., United States |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K161610 |
| Record published | 2022-10-25 |
| Record revised | 2026-02-09 (version 6) |
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 |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 804-09-030 | In distribution | |
| 414926 | In distribution | |
| 800-02-349 | In distribution | |
| 800-01-335 | In distribution | |
| 803-95-001 | In distribution | |
| 803-03-306 | In distribution | |
| 800-05-213 | In distribution | |
| 800-01-359 | In distribution | |
| 800-03-026 | In distribution | |
| 800-01-330 | In distribution | |
| 804-00-097 | In distribution | |
| 800-04-092 | In distribution | |
| 800-04-018 | In distribution | |
| 800-02-353 | In distribution | |
| 800-02-409 | In distribution | |
| 804-06-300 | In distribution | |
| 800-04-089 | In distribution | |
| 804-03-037 | In distribution | |
| 800-01-255 | In distribution | |
| S-201765 | In distribution | |
| 414951 | In distribution | |
| 800-01-429 | In distribution | |
| 800-01-339 | In distribution | |
| 414930 | In distribution | |
| 800-04-013 | In distribution | |
| 800-05-029 | In distribution | |
| 801-06-009 | In distribution | |
| 803-61-207 | In distribution | |
| 800-04-024 | In distribution | |
| 804-06-446 | In distribution | |
| 802-05-105 | In distribution | |
| 801-01-654 | In distribution | |
| 800-02-366 | In distribution | |
| 800-01-365 | In distribution | |
| S-201808 | In distribution | |
| 801-01-013 | In distribution | |
| 803-61-023 | In distribution | |
| 803-02-102 | In distribution | |
| 800-01-428 | In distribution | |
| 804-06-157 | In distribution | |
| 801-04-111 | In distribution | |
| 801-05-080 | In distribution | |
| 804-03-003 | In distribution | |
| 800-01-393 | In distribution | |
| 804-06-322 | In distribution | |
| 801-01-055 | In distribution | |
| 800-04-027 | In distribution | |
| 800-02-379 | In distribution | |
| 800-04-015 | In distribution | |
| 801-06-075 | In distribution | |
| S-201087 | In distribution | |
| 803-05-257 | In distribution | |
| 803-95-006 | In distribution | |
| 800-02-341 | In distribution | |
| 804-03-054 | In distribution | |
| 800-01-334 | In distribution | |
| 800-02-344 | In distribution | |
| 801-04-141 | In distribution | |
| 800-01-430 | In distribution | |
| 801-01-176 | In distribution | |
| 803-11-000 | In distribution | |
| 800-06-008 | In distribution | |
| 800-01-368 | In distribution | |
| 801-05-026 | In distribution | |
| 800-01-426 | In distribution | |
| 800-03-044 | In distribution | |
| 800-01-423 | In distribution | |
| 800-01-398 | In distribution | |
| 800-01-354 | In distribution | |
| S-201921 | In distribution | |
| 801-01-017 | In distribution | |
| 803-15-015 | In distribution | |
| 801-03-005 | In distribution | |
| 803-61-206 | In distribution | |
| 800-01-420 | In distribution | |
| 800-03-047 | In distribution | |
| 800-05-003 | In distribution | |
| 414922 | In distribution | |
| 800-01-361 | In distribution | |
| 801-06-001 | In distribution | |
| 801-06-010 | In distribution | |
| 414929 | In distribution | |
| 800-02-304 | In distribution | |
| 804-00-011 | In distribution | |
| 804-00-200 | In distribution | |
| 804-25-022 | In distribution | |
| 804-06-057 | In distribution | |
| 804-00-084 | In distribution | |
| 800-05-033 | In distribution | |
| 800-02-343 | In distribution | |
| 800-02-340 | In distribution | |
| 801-06-026 | In distribution | |
| 804-00-012 | In distribution | |
| 804-00-088 | In distribution | |
| 801-04-010 | In distribution | |
| 800-01-389 | In distribution | |
| 804-09-042 | In distribution | |
| 800-01-018 | In distribution | |
| S-201971 | In distribution | |
| 803-03-085 | In distribution | |
| 414925 | In distribution | |
| 800-03-046 | In distribution | |
| 804-06-058 | In distribution | |
| 801-05-053 | In distribution | |
| 801-05-057 | In distribution | |
| 800-03-042 | In distribution | |
| 800-01-001 | In distribution | |
| S-201953 | In distribution | |
| 804-09-032 | In distribution | |
| 803-10-007 | In distribution | |
| 800-01-381 | In distribution | |
| 800-02-301 | In distribution | |
| 801-04-110 | In distribution | |
| 804-00-086 | In distribution | |
| 804-01-019 | In distribution | |
| 800-01-360 | In distribution | |
| 800-02-365 | In distribution | |
| 800-02-302 | In distribution | |
| 800-01-396 | In distribution | |
| 803-61-208 | In distribution | |
| 804-05-120 | In distribution | |
| S-201972 | In distribution | |
| 800-01-257 | In distribution | |
| 801-04-112 | In distribution | |
| 800-01-379 | In distribution | |
| 801-04-011 | In distribution | |
| 803-95-003 | In distribution | |
| 801-05-054 | In distribution | |
| S-201956 | In distribution | |
| 800-08-002 | In distribution | |
| 414800 | In distribution | |
| 414923 | In distribution | |
| 801-06-029 | In distribution | |
| 801-03-046 | In distribution | |
| 801-05-002 | In distribution | |
| 800-02-354 | In distribution | |
| 801-05-018 | In distribution | |
| 804-06-313 | In distribution | |
| 800-04-042 | In distribution | |
| 801-05-072 | In distribution | |
| 801-06-036 | In distribution | |
| 800-01-362 | In distribution | |
| 800-01-370 | In distribution | |
| 600-55-705 | In distribution | |
| 800-02-359 | In distribution | |
| 803-02-047 | In distribution | |
| 804-06-002 | In distribution | |
| 801-04-181 | In distribution | |
| 801-05-078 | In distribution | |
| 800-01-364 | In distribution | |
| 801-05-004 | In distribution | |
| 800-04-016 | In distribution | |
| 800-99-165 | In distribution | |
| 800-01-367 | In distribution | |
| 801-04-113 | In distribution | |
| 800-03-043 | In distribution | |
| 801-01-662 | In distribution | |
| 800-02-413 | In distribution | |
| 804-15-103 | In distribution | |
| 801-04-047 | In distribution | |
| 800-04-093 | In distribution | |
| 804-03-056 | In distribution | |
| 800-01-397 | In distribution | |
| 800-01-369 | In distribution | |
| S-201729 | In distribution | |
| 800-04-008 | In distribution | |
| 800-03-009 | In distribution | |
| 800-04-020 | In distribution | |
| S-201770 | In distribution | |
| 804-06-055 | In distribution | |
| 803-03-301 | In distribution | |
| 801-06-028 | In distribution | |
| 800-04-012 | In distribution | |
| 800-04-014 | In distribution | |
| 600-50-004 | In distribution | |
| 801-05-052 | In distribution | |
| 801-01-138 | In distribution | |
| 801-05-058 | In distribution | |
| 801-05-001 | In distribution | |
| 803-15-106 | In distribution | |
| 800-02-362 | In distribution | |
| 803-02-101 | In distribution | |
| S-201970 | In distribution | |
| 800-04-010 | In distribution | |
| 804-06-081 | In distribution | |
| 803-95-004 | In distribution | |
| 801-06-021 | In distribution | |
| 800-02-345 | In distribution | |
| 800-04-025 | In distribution | |
| 804-06-095 | In distribution | |
| 801-05-008 | In distribution | |
| 801-05-006 | In distribution | |
| 800-01-421 | In distribution | |
| 801-04-180 | In distribution | |
| 801-06-007 | In distribution | |
| 804-09-025 | In distribution | |
| 801-06-023 | In distribution | |
| 801-06-033 | In distribution | |
| S-201922 | In distribution | |
| 800-02-303 | In distribution | |
| S-201920 | In distribution | |
| 800-05-023 | In distribution | |
| 800-01-387 | In distribution | |
| 804-06-346 | In distribution | |
| S-201809 | In distribution | |
| 803-95-008 | In distribution | |
| 804-25-023 | In distribution | |
| 800-01-329 | In distribution | |
| 800-05-004 | In distribution | |
| 803-08-033 | In distribution | |
| 800-01-382 | In distribution | |
| 804-09-033 | In distribution | |
| 803-08-029 | In distribution | |
| 801-04-016 | In distribution | |
| 800-02-410 | In distribution | |
| 803-05-167 | In distribution | |
| 800-01-388 | In distribution | |
| 800-01-260 | In distribution | |
| S-201954 | In distribution | |
| 800-02-382 | In distribution | |
| 414893 | In distribution | |
| 800-02-289 | In distribution | |
| 803-61-202 | In distribution | |
| 803-61-201 | In distribution | |
| 804-06-001 | In distribution | |
| 803-05-163 | In distribution | |
| 800-01-380 | In distribution | |
| 801-06-012 | In distribution | |
| 800-01-399 | In distribution | |
| 801-05-010 | In distribution | |
| 800-01-424 | In distribution | |
| 800-01-076 | In distribution | |
| 804-03-035 | In distribution | |
| 800-04-026 | In distribution | |
| 804-00-090 | In distribution | |
| 803-03-084 | In distribution | |
| 803-03-241 | In distribution | |
| 801-01-653 | In distribution | |
| 800-05-212 | In distribution | |
| 800-01-306 | In distribution | |
| 800-02-351 | In distribution | |
| 800-03-019 | In distribution | |
| 800-02-412 | In distribution | |
| 414896 | In distribution | |
| S-201766 | In distribution | |
| 414806 | In distribution | |
| 801-04-115 | In distribution | |
| 800-01-366 | In distribution | |
| 800-02-417 | In distribution | |
| 803-08-030 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Razek Equipamentos | Razek Equipamentos Ltda | 11,578 |
| Orthopedic Manual Surgical Instrument | Globus Medical, Inc. | 4,784 |
| Instrument | Howmedica Osteonics Corp | 4,539 |
| Orthopedic Manual Surgical Instrument | Ortho Development Corp. | 4,076 |
| Knee Instruments | Medacta International SA | 3,944 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 3,420 |
| Arthrex® | Arthrex, Inc. | 3,106 |
| Spine Instruments | Medacta International SA | 2,892 |
| Orthopedic Manual Surgical Instrument | Medtronic Sofamor Danek, Inc. | 2,766 |
| Hip Instruments | Medacta International SA | 1,904 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 1,756 |
| ReLine | Nuvasive, Inc. | 1,208 |
Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-02-04 | Class II | Device Design | The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant prior to impaction, this may cause off axis loading which ca | 410 devices | |
| 2011-09-28 | Not classified | Device Design | DJO Surgical has determined that the alignment pins cannot be consistently cleaned using the technique provided in the cleaning/sterilization section of the instrument IFU. | 133 Planers | 2013-03-29 |
| 2011-09-28 | Not classified | Device Design | DJO Surgical has determined that the alignment pins cannot be consistently cleaned using the technique provided in the cleaning/sterilization section of the instrument IFU. | 399 Reamers | 2013-03-29 |
| 2010-07-12 | Not classified | Device Design | Complaints indicate product’s distal threaded tip may fracture under certain circumstances. | 104 | 2011-06-30 |
| 2010-04-26 | Not classified | Component design/selection | A crack or complete fracture at the anterior chamfer cut slot may occur on the size 8, 10, and 12 MIKA Speedblocks. | 729 and 67 specials | 2011-12-15 |
| 2005-10-21 | Not classified | Other | Detachable T-handles used in hip instrument sets and shoulder instrument sets may fail during shipment or upon initial use because they were incorrectly assembled. | 141 units. | 2008-04-16 |
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.