Software for Diagnosis/Treatment
4.0MM TI Self-Drilling Schanz Screw 15MM THRD/150MM/STERILE
3manufacturers in China registered for this device type
108catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (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 |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| YU XIN Technology(Huizhou) Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | OSN |
| Device type | Software For Diagnosis/Treatment |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K040701 |
| Record published | 2021-10-13 |
| Record revised | 2025-02-06 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02.252.555S | In distribution | |
| 02.172.640S | In distribution | |
| 04.150.415S | In distribution | |
| 04.250.655S | In distribution | |
| 04.170.635SHA | In distribution | |
| 02.252.670 | In distribution | |
| 02.252.655SHA | In distribution | |
| 04.150.420S | In distribution | |
| 04.150.460SHA | In distribution | |
| 02.172.630 | In distribution | |
| 02.170.535S | In distribution | |
| 04.172.530S | In distribution | |
| 02.172.625 | In distribution | |
| 02.250.655S | In distribution | |
| 04.250.585 | In distribution | |
| 04.152.445S | In distribution | |
| 02.152.445SHA | In distribution | |
| 04.172.630 | In distribution | |
| 02.172.540 | In distribution | |
| 04.172.635 | In distribution | |
| 02.250.540 | In distribution | |
| 02.252.685 | In distribution | |
| 04.250.555SHA | In distribution | |
| 02.150.415 | In distribution | |
| 02.150.460SHA | In distribution | |
| 02.252.670S | In distribution | |
| 02.152.430 | In distribution | |
| 04.150.430 | In distribution | |
| 04.150.445 | In distribution | |
| 04.152.415SHA | In distribution | |
| 02.252.585S | In distribution | |
| 04.252.685 | In distribution | |
| 04.172.640 | In distribution | |
| 04.250.640S | In distribution | |
| 04.172.525SHA | In distribution | |
| 02.252.540SHA | In distribution | |
| 02.150.430 | In distribution | |
| 04.170.630SHA | In distribution | |
| 02.150.435SHA | In distribution | |
| 04.172.535SHA | In distribution | |
| 02.152.415S | In distribution | |
| 02.172.525 | In distribution | |
| 04.170.530 | In distribution | |
| 02.250.585S | In distribution | |
| 02.152.440SHA | In distribution | |
| 04.152.430 | In distribution | |
| 04.172.530SHA | In distribution | |
| 02.172.630SHA | In distribution | |
| 04.150.420 | In distribution | |
| 02.252.685S | In distribution | |
| 04.152.425SHA | In distribution | |
| 04.150.455SHA | In distribution | |
| 02.170.525 | In distribution | |
| 02.172.540SHA | In distribution | |
| 02.152.450SHA | In distribution | |
| 04.152.460SHA | In distribution | |
| 04.172.540SHA | In distribution | |
| 04.252.585 | In distribution | |
| 02.250.570 | In distribution | |
| 04.170.630 | In distribution | |
| 04.172.635S | In distribution | |
| 04.250.540 | In distribution | |
| 02.150.430SHA | In distribution | |
| 02.172.525S | In distribution | |
| 02.250.555 | In distribution | |
| 04.150.415 | In distribution | |
| 02.152.425 | In distribution | |
| 04.172.625S | In distribution | |
| 04.172.525 | In distribution | |
| 02.150.450S | In distribution | |
| 02.252.655S | In distribution | |
| 04.152.450SHA | In distribution | |
| 04.170.625S | In distribution | |
| 04.152.430SHA | In distribution | |
| 02.150.445 | In distribution | |
| 02.170.530 | In distribution | |
| 04.250.655SHA | In distribution | |
| 02.170.640S | In distribution | |
| 02.152.455S | In distribution | |
| 04.252.640S | In distribution | |
| 02.150.455S | In distribution | |
| 04.150.435SHA | In distribution | |
| 02.172.535 | In distribution | |
| 02.252.540 | In distribution | |
| 04.252.670S | In distribution | |
| 02.150.440 | In distribution | |
| 04.252.640 | In distribution | |
| 04.172.640SHA | In distribution | |
| 02.150.455 | In distribution | |
| 02.152.420SHA | In distribution | |
| 04.170.640 | In distribution | |
| 02.172.625SHA | In distribution | |
| 02.150.420S | In distribution | |
| 02.152.425SHA | In distribution | |
| 02.172.525SHA | In distribution | |
| 02.170.630 | In distribution | |
| 04.250.585S | In distribution | |
| 04.150.425SHA | In distribution | |
| 04.172.535 | In distribution | |
| 02.170.635S | In distribution | |
| 04.152.435SHA | In distribution | |
| 02.150.430S | In distribution | |
| 04.170.525S | In distribution | |
| 04.252.670SHA | In distribution | |
| 02.250.540SHA | In distribution | |
| 02.252.640 | In distribution | |
| 04.150.450S | In distribution | |
| 04.172.625SHA | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Maxframe | Synthes Gmbh | 27 |
| Orthofix TrueLok Hexapod System (TL-HEX) V2.0 | Orthofix SRL | 27 |
| Arthrex® | Arthrex, Inc. | 21 |
| Maxframe | Synthes (U.S.A.) LP | 5 |
| Acute QC Strut and Components | Smith & Nephew, Inc. | 5 |
| True Lok System | Orthofix SRL | 3 |
| Smart TSF | Smith & Nephew, Inc. | 3 |
| Orthex | Vilex IN Tennessee, Inc. | 1 |
| Enos Software Guided External Fixation System | Disior OY | 1 |
| Orthex External Fixation System | Orthopediatrics, Corp | 1 |
| Smart Correction | Wishbone Medical Inc. | 1 |
| Orthex | Orthopediatrics, Corp | 1 |
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Microport Orthopedics Inc. | 510(k) number | 2017-09-18 | Class II | Packaging process control | The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead to a loss of sterile pouch integrity, which could impact the products sterility assurance and may lead to serious adverse events such as infec | 48 units | 2021-04-08 |
| Synthes (USA) Products LLC | 510(k) number | 2015-07-29 | Class II | Labeling design | Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. This recall identifies additional Trauma External Fixation System part numbers that should be considered MR | 5306080 | 2016-09-27 |
| Synthes Gmbh | 510(k) number | 2014-04-10 | Class II | Labeling Change Control | Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe. | 5,114,052 | 2016-08-26 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-01-11 | Class II | Nonconforming Material/Component | The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts. | 136 | 2015-08-31 |
| Synthes USA (HQ), Inc. | 510(k) number | 2012-10-12 | Class II | Packaging | It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, it was determined that the incorrect in | 8 | |
| Synthes USA (HQ), Inc. | 510(k) number | 2012-09-28 | Class II | Labeling mix-ups | The insert provided with the product for the specific lot number indicates that this product is MR safe. This product is MR Conditional and is etched as MR Conditional. The insert is incorrect. | 8 | 2015-09-21 |
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.