Parallax Acrylic Resin Cartridge with Tracers-Ta
FDA 510(k) K060425 · Arthrocare Corp.
510(k) numberK060425
Submission
- Device name
- Parallax Acrylic Resin Cartridge with Tracers-Ta
- Applicant
- Arthrocare Corp.
Sunnyvale, CA, US - Received
- February 17, 2006
- Decision date
- July 12, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDN – Cement, Bone, Vertebroplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3027
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Parallax Acrylic Resin Cartridge with Tracers-Ta cleared by the FDA?
Parallax Acrylic Resin Cartridge with Tracers-Ta (K060425) received a 510(k) decision of Substantially Equivalent on July 12, 2006, 145 days after the submission was received.
What is the product code of K060425?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.