Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating
FDA 510(k) K974186 · Orthofix Srl
510(k) numberK974186
Submission
- Device name
- Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating
- Applicant
- Orthofix Srl
Rockville, MD, US - Received
- November 7, 1997
- Decision date
- March 18, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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| K241357 | XT3 SystemJDW · Traditional | Biodynamik, Inc. | 01/22/2025SE |
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| 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 |
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Questions and answers
When was Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating cleared by the FDA?
Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating (K974186) received a 510(k) decision of Substantially Equivalent on March 18, 1998, 131 days after the submission was received.
What is the product code of K974186?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.