510(k) K200933
- Device
- Syntec Non-Sterile Steinmann Pins System
- Applicant
- Syntec Scientific Corporation
- 510(k) number
- K200933
- Product code
- JDW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-05-05
- Date received
- 2020-04-07
- Regulation
- 888.3040
- Classification name
- Pin, Fixation, Threaded
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Nicole Tseng
- Address
- #2, Kung San Rd. Chuan Shing Industrial Zone, Shen Kang Chang Hua TW 50971 50971
FDA Registration Numbers#
- 8043872
- 3011302692
- 2245304
- 3004748528
- 3004215117
- 2249529
- 2431166
- 3014522470
- 3019356409
- 3025141
- 3016438694
- 3005562917
- 3010041511
- 3011295718
- 3030966822
- 3006849754
- 1226074
- 1020279
- 3004369035
- 3009973699
- 2183449
- 3015212339
- 3010041430
- 3008868758
- 1225838
- 3009888740
- 2134947
- 8010468
- 3010155648
- 1226544
- 3014315669
- 3013011598
- 3014315560
- 3014967969
- 1221934
- 3010220595
- 3005641619
- 1000517406
- 3006783837
- 3007993775
- 1822565
- 3014302784
- 3015895045
- 3007887127
- 8031020
- 3004176895
- 2249615
- 3004893332
- 3015216945
- 8043792
- 3013680140
- 1528668
- 1424434
- 1450662
- 3006801265
- 1833986
- 3010667733
- 3021008900
- 3013176080
- 3002807315
- 3002907620
- 1057425
- 9615765
- 1526439
- 2919128
- 1424263
- 1018470
- 3012770122
- 3003108161
- 3013540005
- 1219930
- 1043653
- 3007130914
- 3010178296
- 1720929
- 3010041499
- 3008534770
- 3010331645
- 3033509898
Source Documents#
Other 510(k) Records For Product Code JDW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm | Biodynamik, Inc. | 2026-02-10 |
| K250316 | Meduloc Intramedullary Fracture Fixation (IFF) System | Meduloc, LLC | 2025-10-29 |
| K241357 | XT3 System | Biodynamik, Inc. | 2025-01-22 |
| K223112 | MAVERICK Mini External Fixation System | Smith & Nephew, Inc. | 2022-12-08 |
| K213874 | MAVERICK External Fixation System | Smith & Nephew, Inc. | 2022-02-11 |
| K211508 | Steinmann Pins and Kirschner Wires | Stryker GmbH | 2021-10-05 |
| K210784 | Extended HA Half Pins | Smith & Nephew, Inc. | 2021-04-02 |
| K191803 | Orthopedic Fixation Pin | Tinavi (Anhui) Medical Technologies Co., Ltd. | 2020-04-14 |
| K192768 | Temporary Fixation Pins | Eisertech, LLC | 2019-12-26 |
| K182171 | SMV Scientific K-Wire and Pins | Summit Medventures | 2018-10-25 |
| K163487 | Ultima HA Coated Half Pins and Wire | Vilex IN Tennessee, Inc. | 2017-02-13 |
| K150661 | ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite | Citieffe S.R.L. | 2015-07-07 |
| K132820 | VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES | Vilex, Inc. | 2014-07-23 |
| K140875 | OPTOSSOL COMPRESSION DEVICE SYSTEM | Genossis, LLC | 2014-05-30 |
| K131459 | AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE | Aap Implantate AG | 2013-10-17 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases