Smartlock
Locking L-Plate,w. 5MM BAR,9 HOLE,90 Degree
3manufacturers in China registered for this device type
195catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Kontour (Xi’an) Medical Technology Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 4 |
Record
| Listed by | Stryker Leibinger Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | JEY |
| Device type | Plate, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4760 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K014263 |
| Record published | 2015-07-06 |
| Record revised | 2025-07-30 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 5 |
| Sizes | Length 4 to 46 mm; length 2 cm; angle 90 ° |
| Distribution end date | 2025-03-03 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 21-20514 | Diameter: 2.0 Millimeter | In distribution | |
| 50-20506E | Diameter: 2.0 Millimeter | In distribution | |
| 50-23516E | Diameter: 2.3 Millimeter | In distribution | |
| 50-27516 | Length 16.0 mm | 5 | In distribution |
| 24-20506 | Diameter: 2.0 Millimeter | 4 | In distribution |
| 55-05733 | 3D Plates: 6×2 Holes | In distribution | |
| 21-27510 | Length 10.0 mm | In distribution | |
| 50-23512 | Length 12.0 mm | 5 | In distribution |
| 55-05716 | Number of Screw Holes: 16.0 Holes | In distribution | |
| 92-41628E | Thickness: 2.8 Millimeter | In distribution | |
| 50-20508E | Diameter: 2.0 Millimeter | In distribution | |
| 92-55610 | Number of Screw Holes: 6.0 Holes | In distribution | |
| 21-20504 | Diameter: 2.0 Millimeter | In distribution | |
| 22-23510 | Length 10.0 mm | 2 | In distribution |
| 92-55061 | Bar Length: 2.0 Millimeter | In distribution | |
| 55-05763 | Bar Length: 5.0 Millimeter | In distribution | |
| 55-05781 | Number of Screw Holes: 4.0 Holes | In distribution | |
| 50-23520E | Length 2.0 cm | In distribution | |
| 50-27518 | Diameter: 2.7 Millimeter | 5 | In distribution |
| 50-23510 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 92-55407 | Bar Length: 7.0 Millimeter | In distribution | |
| 24-20505 | Length 5.0 mm | 4 | In distribution |
| 50-23518 | Length 18.0 mm | 5 | In distribution |
| 50-23508E | Diameter: 2.3 Millimeter | In distribution | |
| 50-20504E | Length 4.0 mm | In distribution | |
| 50-20514 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 92-75765 | Bar Length: 5.0 Millimeter | In distribution | |
| 21-27514 | Length 14.0 mm | In distribution | |
| 50-20504 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 92-10563 | Bar Length: 4.0 Millimeter | In distribution | |
| 50-27514E | Diameter: 2.7 Millimeter | In distribution | |
| 92-50720E | Thickness: 2.0 Millimeter | In distribution | |
| 92-50728E | Thickness: 2.8 Millimeter | In distribution | |
| 21-23514 | Diameter: 2.3 Millimeter | In distribution | |
| 22-23512 | Diameter: 2.3 Millimeter | 2 | In distribution |
| 50-20505 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 50-20506 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 92-41620E | Thickness: 2.0 Millimeter | In distribution | |
| 92-40828E | Thickness: 2.8 Millimeter | In distribution | |
| 55-10554 | Bar Length: 6.0 Millimeter | In distribution | |
| 22-23508 | Diameter: 2.3 Millimeter | 2 | In distribution |
| 52-20508 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 21-20516 | Length 16.0 mm | In distribution | |
| 92-40720E | Thickness: 2.0 Millimeter | In distribution | |
| 50-27508 | Length 8.0 mm | 5 | In distribution |
| 92-55568 | Bar Length: 8.0 Millimeter | In distribution | |
| 50-17504 | Diameter: 1.7 Millimeter | 5 | In distribution |
| 21-20508 | Diameter: 2.0 Millimeter | In distribution | |
| 92-55465 | Bar Length: 8.0 Millimeter | In distribution | |
| 92-55410 | Number of Screw Holes: 4.0 Holes | In distribution | |
| 21-23512 | Diameter: 2.3 Millimeter | In distribution | |
| 92-15929 | Bended Plate: 6+17+6 Holes | In distribution | |
| 55-05761 | Bar Length: 2.0 Millimeter | In distribution | |
| 92-10564 | Bar Length: 6.0 Millimeter | In distribution | |
| 50-17506E | Diameter: 1.7 Millimeter | In distribution | |
| 55-05742 | Number of Screw Holes: 7.0 Holes | In distribution | |
| 50-23520 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 92-55119 | Bar Length: 9.0 Millimeter | In distribution | |
| 50-27514 | Length 14.0 mm | 5 | In distribution |
| 50-17505 | Diameter: 1.7 Millimeter | 5 | In distribution |
| 92-40628E | Thickness: 2.8 Millimeter | In distribution | |
| 55-10580 | Length 46.0 mm | In distribution | |
| 50-20520E | Length 2.0 cm | In distribution | |
| 92-40620E | Thickness: 2.0 Millimeter | In distribution | |
| 50-23514E | Diameter: 2.3 Millimeter | In distribution | |
| 21-23518 | Length 18.0 mm | In distribution | |
| 50-20510E | Diameter: 2.0 Millimeter | In distribution | |
| 92-55614 | Bar Length: 14.0 Millimeter | In distribution | |
| 92-10568 | Number of Screw Holes: 4.0 Holes | In distribution | |
| 50-23512E | Diameter: 2.3 Millimeter | In distribution | |
| 50-20508 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 50-23516 | Length 16.0 mm | 5 | In distribution |
| 50-27512 | Diameter: 2.7 Millimeter | 5 | In distribution |
| 50-20505E | Diameter: 2.0 Millimeter | In distribution | |
| 50-17506 | Diameter: 1.7 Millimeter | 5 | In distribution |
| 92-50820E | Thickness: 2.0 Millimeter | In distribution | |
| 92-55554 | Number of Screw Holes: 6.0 Holes | In distribution | |
| 52-23510 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 92-15927 | Bended Plate: 6+15+6 Holes | In distribution | |
| 50-20516 | Length 16.0 mm | 5 | In distribution |
| 52-20504 | Length 4.0 mm | 5 | In distribution |
| 50-20514E | Length 14.0 mm | In distribution | |
| 55-02950 | Number of Screw Holes: 9.0 Holes | 2 | In distribution |
| 92-50620E | Thickness: 2.0 Millimeter | In distribution | |
| 24-20508 | Diameter: 2.0 Millimeter | 4 | In distribution |
| 21-23508 | Length 8.0 mm | In distribution | |
| 92-40728E | Thickness: 2.8 Millimeter | In distribution | |
| 55-10570 | Length 36.0 mm | In distribution | |
| 50-23504 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 21-20512 | Length 12.0 mm | In distribution | |
| 50-23506 | Length 6.0 mm | 5 | In distribution |
| 92-05767 | Bar Length: 7.2 Millimeter | In distribution | |
| 92-55057 | Bar Length: 8.0 Millimeter | In distribution | |
| 55-05765 | Number of Screw Holes: 6.0 Holes | In distribution | |
| 55-05752 | Bar Length: 8.0 Millimeter | In distribution | |
| 92-55607 | Bar Length: 7.0 Millimeter | In distribution | |
| 92-41720E | Thickness: 2.0 Millimeter | In distribution | |
| 50-20518E | Length 18.0 mm | In distribution | |
| 92-55055 | Bar Length: 10.0 Millimeter | In distribution | |
| 21-20506 | Length 6.0 mm | In distribution | |
| 50-27518E | Length 18.0 mm | In distribution | |
| 50-20512E | Diameter: 2.0 Millimeter | In distribution | |
| 21-20507 | Length 7.0 mm | In distribution | |
| 50-23518E | Length 18.0 mm | In distribution | |
| 50-23508 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 92-10567 | Number of Screw Holes: 4.0 Holes | In distribution | |
| 50-17504E | Diameter: 1.7 Millimeter | In distribution | |
| 92-55404 | Number of Screw Holes: 4.0 Holes | In distribution | |
| 24-20507 | Length 7.0 mm | 4 | In distribution |
| 50-20510 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 92-55604 | Bar Length: 4.0 Millimeter | In distribution | |
| 92-55758 | Number of Screw Holes: 8.0 Holes | In distribution | |
| 21-20518 | Length 18.0 mm | In distribution | |
| 50-27510E | Length 10.0 mm | In distribution | |
| 50-23504E | Diameter: 2.3 Millimeter | In distribution | |
| 55-05783 | Number of Screw Holes: 4.0 Holes | In distribution | |
| 21-23506 | Diameter: 2.3 Millimeter | In distribution | |
| 55-05731 | 3D Plates: 2×2 Holes | In distribution | |
| 92-50828E | Thickness: 2.8 Millimeter | In distribution | |
| 50-27520E | Diameter: 2.7 Millimeter | In distribution | |
| 52-23506 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 21-27516 | Diameter: 2.7 Millimeter | In distribution | |
| 92-10561 | Number of Screw Holes: 4.0 Holes | In distribution | |
| 92-41820E | Thickness: 2.0 Millimeter | In distribution | |
| 92-55414 | Bar Length: 14.0 Millimeter | In distribution | |
| 50-23510E | Length 10.0 mm | In distribution | |
| 50-20507 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 50-20512 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 92-55767 | Bar Length: 12.0 Millimeter | In distribution | |
| 50-20507E | Length 7.0 mm | In distribution | |
| 50-23514 | Diameter: 2.3 Millimeter | 5 | In distribution |
| 21-27512 | Diameter: 2.7 Millimeter | In distribution | |
| 50-27508E | Length 8.0 mm | In distribution | |
| 55-05779 | Number of Screw Holes: 8.0 Holes | In distribution | |
| 50-27510 | Diameter: 2.7 Millimeter | 5 | In distribution |
| 24-20504 | Length 4.0 mm | 4 | In distribution |
| 92-10565 | Number of Screw Holes: 4.0 Holes | In distribution | |
| 55-10564 | Bar Length: 6.0 Millimeter | In distribution | |
| 55-02951 | Number of Screw Holes: 9.0 Holes | 2 | In distribution |
| 21-23516 | Length 16.0 mm | In distribution | |
| 50-27505 | Diameter: 2.7 Millimeter | 5 | In distribution |
| 50-27505E | Diameter: 2.7 Millimeter | In distribution | |
| 50-23506E | Diameter: 2.3 Millimeter | In distribution | |
| 92-55567 | Number of Screw Holes: 6.0 Holes | In distribution | |
| 92-10560 | Number of Screw Holes: 4.0 Holes | In distribution | |
| 92-50628E | Thickness: 2.8 Millimeter | In distribution | |
| 50-27520 | Length 2.0 cm | 5 | In distribution |
| 50-20520 | Length 2.0 cm | 5 | In distribution |
| 92-10569 | Number of Screw Holes: 4.0 Holes | In distribution | |
| 50-27516E | Diameter: 2.7 Millimeter | In distribution | |
| 55-10566 | Number of Screw Holes: 6.0 Holes | In distribution | |
| 21-23510 | Length 10.0 mm | In distribution | |
| 55-05758 | Number of Screw Holes: 8.0 Holes | In distribution | |
| 50-27512E | Length 12.0 mm | In distribution | |
| 92-41728E | Thickness: 2.8 Millimeter | In distribution | |
| 92-40820E | Thickness: 2.0 Millimeter | In distribution | |
| 92-55660 | Number of Screw Holes: 6.0 Holes | In distribution | |
| 21-27518 | Length 18.0 mm | In distribution | |
| 50-17505E | Diameter: 1.7 Millimeter | In distribution | |
| 50-20518 | Diameter: 2.0 Millimeter | 5 | In distribution |
| 55-05767 | Bar Length: 12.0 Millimeter | In distribution | |
| 55-10556 | Bar Length: 12.0 Millimeter | In distribution | |
| 21-20505 | Length 5.0 mm | In distribution | |
| 92-55058 | Bar Length: 5.0 Millimeter | In distribution | |
| 92-41828E | Thickness: 2.8 Millimeter | In distribution | |
| 55-05751 | Number of Screw Holes: 5.0 Holes | In distribution | |
| 50-20516E | Diameter: 2.0 Millimeter | In distribution | |
| 21-20510 | Diameter: 2.0 Millimeter | In distribution | |
| 52-27520 | Length 2.0 cm | 5 | Withdrawn |
| 52-20516 | Length 16.0 mm | 5 | Withdrawn |
| 52-27518 | Length 18.0 mm | 5 | Withdrawn |
| 52-23516 | Diameter: 2.3 Millimeter | 5 | Withdrawn |
| 52-23514 | Diameter: 2.3 Millimeter | 5 | Withdrawn |
| 52-20520 | Length 2.0 cm | 5 | Withdrawn |
| 52-20518 | Length 18.0 mm | 5 | Withdrawn |
| 52-27510 | Diameter: 2.7 Millimeter | 5 | Withdrawn |
| 52-20507 | Length 7.0 mm | 5 | Withdrawn |
| 52-23520 | Diameter: 2.3 Millimeter | 5 | Withdrawn |
| 51-17506 | Diameter: 1.7 Millimeter | 5 | Withdrawn |
| 52-23518 | Length 18.0 mm | 5 | Withdrawn |
| 52-23508 | Diameter: 2.3 Millimeter | 5 | Withdrawn |
| 52-20514 | Diameter: 2.0 Millimeter | 5 | Withdrawn |
| 52-27512 | Diameter: 2.7 Millimeter | 5 | Withdrawn |
| 52-23512 | Diameter: 2.3 Millimeter | 5 | Withdrawn |
| 52-27516 | Diameter: 2.7 Millimeter | 5 | Withdrawn |
| 51-17504 | Length 4.0 mm | 5 | Withdrawn |
| 52-20510 | Length 10.0 mm | 5 | Withdrawn |
| 52-20512 | Length 12.0 mm | 5 | Withdrawn |
| 52-20505 | Length 5.0 mm | 5 | Withdrawn |
| 51-17505 | Length 5.0 mm | 5 | Withdrawn |
| 51-19505 | Length 5.0 mm | 5 | Withdrawn |
| 52-27514 | Length 14.0 mm | 5 | Withdrawn |
| 52-27508 | Length 8.0 mm | 5 | Withdrawn |
| 52-20506 | Length 6.0 mm | 5 | Withdrawn |
| 52-23504 | Diameter: 2.3 Millimeter | 5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Plate, Bone | Stryker Leibinger Gmbh & Co. KG | 1,338 |
| Level ONE CMF | KLS-Martin L.P. | 1,160 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 843 |
| OsteoMed | Osteomed | 675 |
| Bioplate® | Bioplate, Inc. | 669 |
| Plate, Bone | Synthes Gmbh | 568 |
| Leforte System Bone Plate | Jeil Medical Corporation | 466 |
| CMF Visionare | Visionare LLC | 421 |
| Level ONE CMF, Sterile | KLS-Martin L.P. | 416 |
| Faico CMF System | Faico Medical, LLC | 361 |
| TraumaOne System | Biomet Microfixation | 357 |
| MatrixMANDIBLE | Synthes Gmbh | 277 |
Showing 12 of 152. All products under Plate, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240651 | 2024-07-12 |
| K230733 | 2023-08-05 |
| K221855 | 2022-11-09 |
| K000594 | 2000-12-08 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Stryker Leibinger USA | 510(k) number | 2008-09-19 | Not classified | Process control | A template is supposed to accompany the product, but it was not included with this lot. | 23 | 2009-12-15 |
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.