Cancellous Screw Washer
FDA 510(k) K963420 · Orthopaedic Biosystems, Ltd.
510(k) numberK963420
Submission
- Device name
- Cancellous Screw Washer
- Applicant
- Orthopaedic Biosystems, Ltd.
Scotsdale, AZ, US - Received
- August 30, 1996
- Decision date
- November 15, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTN – Washer, Bolt Nut
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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More from Vilex, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K000797 | Obl 2.0 MM Mini Tac Anchor, Model 10-1629-01JDR · Special | 04/03/2000SE |
| K982996 | Polymer Obl SB Anchor / Suture CombinationJDR · Traditional | 03/04/1999SE |
| K983169 | Polymer Threaded AnchorMBI · Traditional | 12/16/1998SE |
| K982963 | Polymer Threaded Anchor / Suture CombinationJDI · Traditional | 11/20/1998SE |
| K972326 | Peba Anchor/Suture CombinationMBI · Traditional | 02/06/1998SE |
| K963432 | Guide Wires for Cannulated ScrewsLXT · Traditional | 11/13/1996SE |
| K963433 | Threaded Fixation PinJDW · Traditional | 11/06/1996SE |
| K962779 | Compression ScrewHWC · Traditional | 08/23/1996SN |
| K951451 | Peba Anchor (Multiple Sizes)MBI · Traditional | 10/31/1995SN |
| K942889 | SB AnchorJDR · Traditional | 08/25/1995SE |
Questions and answers
When was Cancellous Screw Washer cleared by the FDA?
Cancellous Screw Washer (K963420) received a 510(k) decision of Substantially Equivalent on November 15, 1996, 77 days after the submission was received.
What is the product code of K963420?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.