Product code JDW
- Device name
- Pin, Fixation, Threaded
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3040
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| 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 |
| K130298 | BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM | Biopro, Inc. | 2013-06-18 |
| K120871 | SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION | Smith & Nephew, Inc. | 2012-06-07 |
| K103001 | ROCKWOOD CLAVICLE PINS | DePuy Orthopaedics, Inc. | 2011-02-17 |
| K102777 | TWISTCUT ENDOSORB SCREWS | Merete Medical GmbH | 2010-12-20 |
| K100414 | PROTOE ENDOSORB SMALL HAMMER TOE PIN | Merete Medical GmbH | 2010-07-02 |
| K083144 | ACUMED CLAVICLE SCREW SYSTEM | Acumed, LLC | 2009-06-16 |
| K072710 | NEXFIX COMPRESSION PIN | Nexa Orthopedics, Inc. | 2007-11-08 |
| K071540 | SBI TITANIUM THREADED PIN | Small Bone Innovations, Inc. | 2007-08-08 |
| K061599 | PIN SCREW | Bk Meditech, Co., Ltd. | 2006-07-26 |
| K061493 | APEX PINS | Stryker Howmedica Osteonics | 2006-07-07 |
| K061498 | ALLOFIX ANCHOR, 5.0 MM ANCHOR | Musculoskeletal Transplant Foundation | 2006-07-06 |
| K053513 | T-PIN | Union Surgical, LLC | 2006-01-13 |
| K051740 | TAPERED COMPRESSION PIN | Nexa Orthopedics, Inc. | 2005-09-06 |
| K040765 | SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS | Synthes (Usa) | 2004-04-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08032909624256 | ST.A.R. 90 F4 | CITIEFFE SRL | 2024-09-11 |
| 08032909624744 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624881 | DOLPHIX | CITIEFFE SRL | 2015-10-21 |
| 08032909624874 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624867 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624850 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624843 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624836 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624829 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624812 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624805 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624799 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624782 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624775 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624768 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624751 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909623600 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624720 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624713 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624218 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624201 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624195 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624188 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624171 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624164 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624157 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624140 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909623952 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909623792 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909623624 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |