RC Loop /Dual Orthocord Suture,Rc Loop W/Ethibond Suture,Rc Loop W/Panacryl Suture
FDA 510(k) K060553 · Depuy Mitek, A Johnson & Johnson Company
510(k) numberK060553
Submission
- Device name
- RC Loop /Dual Orthocord Suture,Rc Loop W/Ethibond Suture,Rc Loop W/Panacryl Suture
- Applicant
- Depuy Mitek, A Johnson & Johnson Company
Raynham, MA, US - Received
- March 1, 2006
- Decision date
- May 4, 2006
- 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 RC Loop /Dual Orthocord Suture,Rc Loop W/Ethibond Suture,Rc Loop W/Panacryl Suture cleared by the FDA?
RC Loop /Dual Orthocord Suture,Rc Loop W/Ethibond Suture,Rc Loop W/Panacryl Suture (K060553) received a 510(k) decision of Substantially Equivalent on May 4, 2006, 64 days after the submission was received.
What is the product code of K060553?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.