Block Stop Wires
FDA 510(k) K964087 · Ferguson Medical
510(k) numberK964087
Submission
- Device name
- Block Stop Wires
- Applicant
- Ferguson Medical
Chico, CA, US - Received
- October 11, 1996
- Decision date
- November 25, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
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| K033153 | Dicom TheaterLLZ · Traditional | 04/23/2004SE |
| K963794 | PunctureneedleKNW · Traditional | 03/19/1998SE |
| K962615 | Tumorlocalizer MRIMIG · Traditional | 03/19/1998SE |
| K971813 | EmblaOLV · Traditional | 01/16/1998SE |
| K972219 | Orthopedic Plate SystemHRS · Traditional | 11/20/1997SE |
| K972217 | Orthopedic Screw SystemHWC · Traditional | 11/20/1997SE |
| K970819 | TargobeamJAK · Traditional | 07/14/1997SE |
| K970280 | Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Per-Trochanteroam…HSB · Traditional | 05/22/1997SE |
| K970258 | Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck…HRS · Traditional | 05/22/1997SE |
| K970257 | Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Sub-Trochanterian…HSB · Traditional | 05/22/1997SE |
Questions and answers
When was Block Stop Wires cleared by the FDA?
Block Stop Wires (K964087) received a 510(k) decision of Substantially Equivalent on November 25, 1996, 45 days after the submission was received.
What is the product code of K964087?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.