AVS
PL Spacer Inserter With Laser Marking
53manufacturers in China registered for this device type
109catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Stryker GmbH, Switzerland |
|---|---|
| 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 |
| Premarket notification | Exempt |
| Record published | 2019-12-02 |
| Record revised | 2025-03-17 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Height 4 to 18 mm; width 8 to 16 mm; length 20 to 33 mm; angle 0 to 4 °; depth 12 to 14 mm |
| Distribution end date | 2025-03-17 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 48329404 | Depth 14.0 mm | In distribution |
| 48329412 | Width 16.0 mm | In distribution |
| 48350008 | In distribution | |
| 48350951 | In distribution | |
| 48352112 | Height 12.0 mm | In distribution |
| 48350018 | Angle 4.0 ° | In distribution |
| 48352209 | Length 20.0 mm | In distribution |
| 48352107 | Length 20.0 mm | In distribution |
| 48321214 | In distribution | |
| 48350004 | In distribution | |
| 48328000C | In distribution | |
| 48352212 | Angle 0.0 ° | In distribution |
| 48350001 | In distribution | |
| 48350952 | In distribution | |
| 48389411 | Height 11.0 mm | In distribution |
| 48350911 | In distribution | |
| 48329211 | Depth 12.0 mm | In distribution |
| 48329210 | Width 14.0 mm | In distribution |
| 48352013 | Width 8.0 mm | In distribution |
| 48350010 | Angle 0.0 ° | In distribution |
| 48329409 | Depth 14.0 mm | In distribution |
| 48389250 | In distribution | |
| 48350011 | Length 30.0 mm | In distribution |
| 48352007 | Length 20.0 mm | In distribution |
| 48352010 | Angle 0.0 ° | In distribution |
| 48352015 | Length 20.0 mm | In distribution |
| 48329406 | Height 6.0 mm | In distribution |
| 48389410 | Height 10.0 mm | In distribution |
| 48389415 | Height 15.0 mm | In distribution |
| 48389300 | In distribution | |
| 48329060 | In distribution | |
| 48352206 | Angle 0.0 ° | In distribution |
| 48352116 | Width 11.0 mm | In distribution |
| 48329405 | Height 5.0 mm | In distribution |
| 48350013 | Length 33.0 mm | In distribution |
| 48352109 | Angle 0.0 ° | In distribution |
| 48352108 | Height 8.0 mm | In distribution |
| 48352012 | Angle 0.0 ° | In distribution |
| 48389150 | In distribution | |
| 48389407 | Height 7.0 mm | In distribution |
| 48350009 | In distribution | |
| 48352216 | Angle 0.0 ° | In distribution |
| 48389408 | Height 8.0 mm | In distribution |
| 48389413 | Height 13.0 mm | In distribution |
| 48329050 | In distribution | |
| 48350923 | In distribution | |
| 48350023 | Width 11.0 mm | In distribution |
| 48389417 | Height 17.0 mm | In distribution |
| 48329212 | Width 14.0 mm | In distribution |
| 48389500 | In distribution | |
| 48389350 | In distribution | |
| 48350911L | In distribution | |
| 48329204 | Width 14.0 mm | In distribution |
| 48389414 | Height 14.0 mm | In distribution |
| 48352214 | Length 20.0 mm | In distribution |
| 48352211 | Height 11.0 mm | In distribution |
| 48352111 | Width 11.0 mm | In distribution |
| 48352009 | Width 8.0 mm | In distribution |
| 48352215 | Angle 0.0 ° | In distribution |
| 48329205 | Depth 12.0 mm | In distribution |
| 48352210 | Length 20.0 mm | In distribution |
| 48329207 | Width 14.0 mm | In distribution |
| 48329209 | Width 14.0 mm | In distribution |
| 48389409 | Height 9.0 mm | In distribution |
| 48352213 | Width 9.0 mm | In distribution |
| 48352113 | Width 11.0 mm | In distribution |
| 48352014 | Height 14.0 mm | In distribution |
| 48389416 | Height 16.0 mm | In distribution |
| 48350952L | Width 9.0 mm | In distribution |
| 48350022 | Width 9.0 mm | In distribution |
| 48350951L | Width 11.0 mm | In distribution |
| 48350003 | In distribution | |
| 48370000 | In distribution | |
| 48350006 | In distribution | |
| 48329408 | Height 8.0 mm | In distribution |
| 48352207 | Width 9.0 mm | In distribution |
| 48329206 | Width 14.0 mm | In distribution |
| 48329208 | Height 8.0 mm | In distribution |
| 48389200 | In distribution | |
| 48350002 | In distribution | |
| 48352106 | Width 11.0 mm | In distribution |
| 48350000 | In distribution | |
| 48352115 | Angle 0.0 ° | In distribution |
| 48352008 | Height 8.0 mm | In distribution |
| 48350963 | In distribution | |
| 48352006 | Height 6.0 mm | In distribution |
| 48329410 | Depth 14.0 mm | In distribution |
| 48329407 | Depth 14.0 mm | In distribution |
| 48389418 | Height 18.0 mm | In distribution |
| 48329411 | Depth 14.0 mm | In distribution |
| 48352208 | Width 9.0 mm | In distribution |
| 48352114 | Length 20.0 mm | In distribution |
| 48389550 | In distribution | |
| 48329100 | In distribution | |
| 48329000 | In distribution | |
| 48389100 | In distribution | |
| 48389412 | Height 12.0 mm | In distribution |
| 48352110 | Width 11.0 mm | In distribution |
| 48352011 | Height 11.0 mm | In distribution |
| 48352016 | Angle 0.0 ° | In distribution |
| 48329500 | Withdrawn | |
| 48329140 | Withdrawn | |
| 48350920 | Withdrawn | |
| 48329600 | Withdrawn | |
| 48322228 | Withdrawn | |
| 48350950 | Withdrawn | |
| 48329800 | Withdrawn | |
| 48350910 | Withdrawn | |
| 48350960 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K941605 | 1994-08-05 |
| K843942 | 1985-04-15 |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2025-03-28 | Class II | Device Design | The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery. | 1588 units | |
| 2025-03-28 | Class II | Device Design | The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery. | 6407 units | |
| 2017-11-09 | Class II | Environmental control | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 320 | 2019-04-16 |
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.