Panalok RC Quickanchor Plus, Model 212130, 212730; Dual Suture Panalok RC Quickanchor Pllus, Models 212132, 212732
FDA 510(k) K041117 · Depuy Mitek
510(k) numberK041117
Submission
- Device name
- Panalok RC Quickanchor Plus, Model 212130, 212730; Dual Suture Panalok RC Quickanchor Pllus, Models 212132, 212732
- Applicant
- Depuy Mitek
Norwood, MA, US - Received
- April 29, 2004
- Decision date
- May 28, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDR – Staple, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Panalok RC Quickanchor Plus, Model 212130, 212730; Dual Suture Panalok RC Quickanchor Pllus, Models 212132, 212732 cleared by the FDA?
Panalok RC Quickanchor Plus, Model 212130, 212730; Dual Suture Panalok RC Quickanchor Pllus, Models 212132, 212732 (K041117) received a 510(k) decision of Substantially Equivalent on May 28, 2004, 29 days after the submission was received.
What is the product code of K041117?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.