Affiniti
Glenoid Drill Guide Handle
53manufacturers in China registered for this device type
67catalogue numbers in this listing
3recalls 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 | Tornier Inc., 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, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-08-09 |
| Record revised | 2023-10-11 (version 2) |
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 |
| Sizes | Outer diameter 8 to 56 mm; height 15 to 21 mm; length 200 to 220 mm |
| Distribution end date | 2022-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9723084 | Outer Diameter 40 mm | In distribution |
| 9723093 | Outer Diameter 52 mm | In distribution |
| 9000462 | Length 220 mm | In distribution |
| 9723087 | Outer Diameter 44 mm | In distribution |
| 9000460 | Outer Diameter 10 mm | In distribution |
| 9723096 | Height 15 mm | In distribution |
| 9723092 | Height 21 mm | In distribution |
| 9000464 | Outer Diameter 14 mm | In distribution |
| 9723097 | Height 18 mm | In distribution |
| 9000458 | Length 200 mm | In distribution |
| 9723095 | Height 21 mm | In distribution |
| 9723085 | Height 18 mm | In distribution |
| 9723094 | Outer Diameter 52 mm | In distribution |
| 9723089 | Outer Diameter 44 mm | In distribution |
| 9723088 | Outer Diameter 44 mm | In distribution |
| 9723090 | Outer Diameter 48 mm | In distribution |
| 9723091 | Outer Diameter 48 mm | In distribution |
| 9723086 | Height 21 mm | In distribution |
| 9723098 | Outer Diameter 56 mm | In distribution |
| 9000253 | Height 18 mm | Withdrawn |
| 9000404 | Outer Diameter 52 mm | Withdrawn |
| 9000526 | Size 18 mm | Withdrawn |
| 9000260 | Withdrawn | |
| 9000257 | Outer Diameter 56 mm | Withdrawn |
| 9000233 | Outer Diameter 52 mm | Withdrawn |
| 9000240 | Outer Diameter 40 mm | Withdrawn |
| 9000406 | Height 18 mm | Withdrawn |
| 9000254 | Outer Diameter 52 mm | Withdrawn |
| 9000242 | Outer Diameter 40 mm | Withdrawn |
| 9000237 | Outer Diameter 56 mm | Withdrawn |
| 9000249 | Height 18 mm | Withdrawn |
| 9000527 | Size 21 mm | Withdrawn |
| 9000201 | Size 44 | Withdrawn |
| 9000264 | Withdrawn | |
| 9000403 | Outer Diameter 48 mm | Withdrawn |
| 9000407 | Outer Diameter 56 mm | Withdrawn |
| 9000230 | Outer Diameter 48 mm | Withdrawn |
| 9000222 | Outer Diameter 40 mm | Withdrawn |
| 9000238 | Height 21 mm | Withdrawn |
| 9000294 | Withdrawn | |
| 9000225 | Outer Diameter 44 mm | Withdrawn |
| 9000241 | Height 18 mm | Withdrawn |
| 9000204 | Size 56 | Withdrawn |
| 9000221 | Height 18 mm | Withdrawn |
| 9000400 | Outer Diameter 44 mm | Withdrawn |
| 9000402 | Height 18 mm | Withdrawn |
| 9000246 | Outer Diameter 44 mm | Withdrawn |
| 9000200 | Size 40 | Withdrawn |
| 9000344 | Size 44 | Withdrawn |
| 9000401 | Height 21 mm | Withdrawn |
| 9000244 | Outer Diameter 44 mm | Withdrawn |
| 9000245 | Height 18 mm | Withdrawn |
| 9000229 | Height 18 mm | Withdrawn |
| 9000234 | Height 21 mm | Withdrawn |
| 9000252 | Height 15 mm | Withdrawn |
| 9000250 | Height 21 mm | Withdrawn |
| 9000340 | Size 40 | Withdrawn |
| 9000203 | Size 52 | Withdrawn |
| 9000352 | Size 52 | Withdrawn |
| 9000356 | Size 56 | Withdrawn |
| 9000248 | Height 15 mm | Withdrawn |
| 9000405 | Outer Diameter 52 mm | Withdrawn |
| 9000348 | Size 48 | Withdrawn |
| 9000226 | Height 21 mm | Withdrawn |
| 9000258 | Outer Diameter 56 mm | Withdrawn |
| 9000256 | Outer Diameter 56 mm | Withdrawn |
| 9000202 | Size 48 | Withdrawn |
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
2 of these are 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 |
|---|---|---|---|---|---|
| 2022-05-03 | Class II | Device Design | The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container. | 1066 units | |
| 2014-09-19 | Class II | Device Design | Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer | 38 | 2016-10-31 |
| 2009-10-16 | Not classified | Other | The adapters are able to come apart when a retaining ring in the proximal end of the adapter can dislodge from the retaining ring groove and the two ends of the adapter fall apart and are unable to be reassembled without special tools and k | 127 pieces | 2012-04-11 |
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.