Colbalt Alloy Orthopaedic Wire
FDA 510(k) K811500 · Osteonics Corp.
510(k) numberK811500
Submission
- Device name
- Colbalt Alloy Orthopaedic Wire
- Applicant
- Osteonics Corp.
Mchenry, IL, US - Received
- May 27, 1981
- Decision date
- June 18, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Colbalt Alloy Orthopaedic Wire cleared by the FDA?
Colbalt Alloy Orthopaedic Wire (K811500) received a 510(k) decision of Substantially Equivalent on June 18, 1981, 22 days after the submission was received.
What is the product code of K811500?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.