Orthopedic Smooth Pin Fixation
FDA 510(k) K932348 · Osteomed Corp.
510(k) numberK932348
Submission
- Device name
- Orthopedic Smooth Pin Fixation
- Applicant
- Osteomed Corp.
Fort Wayne, IN, US - Received
- May 14, 1993
- Decision date
- March 1, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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More from OSSIO , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K212570 | OsteoPlan SystemDZJ · Traditional | 02/11/2022SE |
| K203479 | ExtremiLOCK Lateral Ankle Fusion PlatesHRS · Traditional | 02/24/2021SE |
| K202105 | OsteoMed ExtremiFix Mini & Small System TrayKCT · Traditional | 10/29/2020SE |
| K202680 | OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemHWC · Special | 10/15/2020SE |
| K173391 | OsteoMed QuickFix Hybrid MMF Sterilization TrayKCT · Traditional | 05/10/2018SE |
| K162542 | OsteoMed PINNACLE DriverHBE · Traditional | 05/19/2017SE |
| K163303 | OsteoMed ExtremiFix Mid and Large Screw SystemHWC · Traditional | 04/04/2017SE |
| K162544 | OsteoMed PINNACLE DriverKMW · Traditional | 04/04/2017SE |
| K161041 | OsteoMed ExtremiLOCK Wrist Plating SystemHRS · Special | 05/19/2016SE |
| K152145 | OsteoMed ExtremiLOCK Wrist Plating SystemHRS · Traditional | 12/21/2015SE |
Questions and answers
When was Orthopedic Smooth Pin Fixation cleared by the FDA?
Orthopedic Smooth Pin Fixation (K932348) received a 510(k) decision of Substantially Equivalent on March 1, 1994, 291 days after the submission was received.
What is the product code of K932348?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.