510(k) K191803
- Device
- Orthopedic Fixation Pin
- Applicant
- Tinavi (Anhui) Medical Technologies Co., Ltd.
- 510(k) number
- K191803
- Product code
- JDW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-04-14
- Date received
- 2019-07-03
- Regulation
- 888.3040
- Classification name
- Pin, Fixation, Threaded
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jianhua Jiang
- Address
- Bldg. 5,Robot Industrial Base Of Tuscity, Jinxiu Ave./Susong Rd., Hefei CN 230601 230601
FDA Registration Numbers#
- 3011301313
- 2249615
- 1835251
- 1221934
- 3013176080
- 3008951116
- 1528668
- 3042903229
- 3001239363
- 3006460162
- 2431166
- 3010220595
- 3006849754
- 2029275
- 3010041511
- 9611274
- 3005061536
- 2648623
- 1835831
- 3004748528
- 3014315669
- 1833920
- 3008110533
- 3003639920
- 1450662
- 2936485
- 1526439
- 3010470577
- 3033536312
- 1833986
- 3007125392
- 3025141
- 3016438694
- 1825034
- 1226074
- 1424434
- 3006783837
- 1000517406
- 3015216945
- 3013540005
- 1828464
- 3011277306
- 3000270450
- 3015207155
- 3008812251
- 3010405304
- 1424263
- 3035366890
- 2183946
- 3005562917
- 3008534770
- 3014302784
- 1643264
- 3010673850
- 1043534
- 3030966822
- 3011656326
- 3015542154
- 3014129047
- 3009417901
- 3011137372
- 3014967969
- 9611863
- 3014315560
- 3015946784
- 2183449
- 9615765
- 8010468
- 2249529
- 3005809810
- 8043872
- 3004464325
- 3007366790
- 2919128
- 3008812560
- 1051526
- 3014522470
- 3005180920
- 1060840
- 3007923096
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 |
| K200933 | Syntec Non-Sterile Steinmann Pins System | Syntec Scientific Corporation | 2020-05-05 |
| 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