PediLoc Tibia
3.5MM Trans-Physeal Locking Screw, 34MM Long, 10MM Unthreaded TIP
31manufacturers in China registered for this device type
42catalogue numbers in this listing
2510(k) clearances naming this product code
7recalls on this code
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Orthopediatrics, Corp, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K111086 |
| Record published | 2017-07-30 |
| Record revised | 2024-02-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-0903-3834 | In distribution | |
| 00-0903-3868 | In distribution | |
| 00-0903-3970 | In distribution | |
| 00-0903-3960 | In distribution | |
| 00-0903-3954 | In distribution | |
| 00-0903-3956 | In distribution | |
| 00-0903-3932 | In distribution | |
| 00-0903-3846 | In distribution | |
| 00-0903-3870 | In distribution | |
| 00-0903-3842 | In distribution | |
| 00-0903-3944 | In distribution | |
| 00-0903-3852 | In distribution | |
| 00-0903-3958 | In distribution | |
| 00-0903-3948 | In distribution | |
| 00-0903-3854 | In distribution | |
| 00-0903-3836 | In distribution | |
| 00-0903-3962 | In distribution | |
| 00-0903-3850 | In distribution | |
| 00-0903-3838 | In distribution | |
| 00-0903-3936 | In distribution | |
| 00-0903-3966 | In distribution | |
| 00-0903-3844 | In distribution | |
| 00-0903-3950 | In distribution | |
| 00-0903-3848 | In distribution | |
| 00-0903-3946 | In distribution | |
| 00-0903-3942 | In distribution | |
| 00-0903-3832 | In distribution | |
| 00-0903-3866 | In distribution | |
| 00-0903-3952 | In distribution | |
| 00-0903-3864 | In distribution | |
| 00-0903-3830 | In distribution | |
| 00-0903-3934 | In distribution | |
| 00-0903-3938 | In distribution | |
| 00-0903-3856 | In distribution | |
| 00-0903-3930 | In distribution | |
| 00-0903-3840 | In distribution | |
| 00-0903-3860 | In distribution | |
| 00-0903-3940 | In distribution | |
| 00-0903-3964 | In distribution | |
| 00-0903-3858 | In distribution | |
| 00-0903-3862 | In distribution | |
| 00-0903-3968 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190324 | 2019-07-05 |
| K082949 | 2008-11-25 |
Recalls
7 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 |
|---|---|---|---|---|---|
| 2016-07-27 | Class II | Labeling mix-ups | OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled. | 41 | 2017-03-24 |
| 2016-07-27 | Class II | Labeling mix-ups | OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled. | 41 | 2017-03-24 |
| 2014-01-08 | Class II | Labeling mix-ups | OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical Screw, Lot # 009SV because the device within the package may be incorrect. These packages incorrectly contain a 3.5mm Non Locking Cortical Scre | 12 units | 2014-04-23 |
| 2013-07-24 | Class II | Process design | OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Only drill bits that are in their original packaging are being recalled. The description on the package of this drill bit has a wrong si | 68 | 2013-08-26 |
| 2013-04-19 | Class II | Device Design | Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively. | 130 devices were shipped | 2013-09-19 |
| 2013-04-19 | Class II | Device Design | Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively. | 130 devices were shipped | 2013-09-19 |
| 2013-04-19 | Class II | Device Design | Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively. | 130 devices were shipped | 2013-09-19 |
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.