Threaded Pins
FDA 510(k) K920188 · Kirschner Medical Corp.
510(k) numberK920188
Submission
- Device name
- Threaded Pins
- Applicant
- Kirschner Medical Corp.
Timonium, MD, US - Received
- January 15, 1992
- Decision date
- May 12, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBJ – Fastener, Fixation, Biodegradable, Hard Tissue
- Device class
- Class III (high risk)
- Implant
- Yes
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| K942891 | Summit Total Hip SystemMEH · Traditional | 11/02/1994SE |
| K941486 | Integrity Total Hip System, Non-PorousJDI · Traditional | 09/20/1994SE |
| K933843 | Line Extension for Kirschner Performance Total Knee System, Porous CoatedJWH · Traditional | 08/05/1994SE |
| K935951 | Kirschner C-2 Osteocap Total Hip SystemJDI · Traditional | 07/18/1994SE |
| K935206 | Kirschner Integrity Acetabular Cup ModificationJDI · Traditional | 07/13/1994SE |
| K934589 | Kirschner Performance Total Knee System Porous CoatedJWH · Traditional | 07/13/1994SN |
| K934694 | Kirschner Zirconia Femoral HeadLZO · Traditional | 05/18/1994SE |
| K921837 | Medicam 900 Insufflator with AccessoriesHIF · Traditional | 02/05/1993SE |
Questions and answers
When was Threaded Pins cleared by the FDA?
Threaded Pins (K920188) received a 510(k) decision of Substantially Equivalent on May 12, 1993, 483 days after the submission was received.
What is the product code of K920188?
The FDA product code is MBJ – Fastener, Fixation, Biodegradable, Hard Tissue, a Class III (high risk) device.