ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite
FDA 510(k) K150661 · Citieffe S.R.L.
510(k) numberK150661
Submission
- Device name
- ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite
- Applicant
- Citieffe S.R.L.
Calderara Di Reno, IT - Received
- March 13, 2015
- Decision date
- July 7, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JDW – Pin, Fixation, Threaded
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDW
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|---|---|---|---|
| K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmJDW · Special | Biodynamik, Inc. | 02/10/2026SE |
| K250316 | Meduloc Intramedullary Fracture Fixation (IFF) SystemJDW · Traditional | Meduloc, LLC | 10/29/2025SE |
| K241357 | XT3 SystemJDW · Traditional | Biodynamik, Inc. | 01/22/2025SE |
| K223112 | MAVERICK Mini External Fixation SystemJDW · Traditional | Smith & Nephew, Inc. | 12/08/2022SE |
| K213874 | MAVERICK External Fixation SystemJDW · Traditional | Smith & Nephew, Inc. | 02/11/2022SE |
| K211508 | Steinmann Pins and Kirschner WiresJDW · Traditional | Stryker GmbH | 10/05/2021SE |
| K210784 | Extended HA Half PinsJDW · Special | Smith & Nephew, Inc. | 04/02/2021SE |
| K200933 | Syntec Non-Sterile Steinmann Pins SystemJDW · Special | Syntec Scientific Corporation | 05/05/2020SE |
| K191803 | Orthopedic Fixation PinJDW · Traditional | Tinavi (Anhui) Medical Technologies Co., Ltd. | 04/14/2020SE |
| K192768 | Temporary Fixation PinsJDW · Traditional | Eisertech, LLC | 12/26/2019SE |
More from Eisertech, LLC
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|---|---|---|
| K250197 | Estremo Fibular NailHSB · Traditional | 10/17/2025SE |
| K183666 | EBA One Nailing SystemHSB · Traditional | 11/14/2019SE |
| K181540 | Estremo Citieffe Nailing SystemHSB · Traditional | 01/16/2019SE |
| K180150 | PL8 Wrist Reconstruction PlateHRS · Traditional | 08/02/2018SE |
| K163323 | Dolphix® External Fixation System MR ConditionalKTT · Traditional | 03/20/2017SE |
| K132363 | Dolphix External Fixation SystemKTT · Traditional | 01/16/2014SE |
| K131005 | EBA2 Femoral Nailing SystemHSB · Special | 06/25/2013SE |
Questions and answers
When was ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite cleared by the FDA?
ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite (K150661) received a 510(k) decision of Substantially Equivalent on July 7, 2015, 116 days after the submission was received.
What is the product code of K150661?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.