Plus Fracture Head Prosthesis
FDA 510(k) K990309 · Plus Orthopedics
510(k) numberK990309
Submission
- Device name
- Plus Fracture Head Prosthesis
- Applicant
- Plus Orthopedics
San Diego, CA, US - Received
- February 1, 1999
- Decision date
- March 15, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWL – Prosthesis, Hip, Hemi-, Femoral, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Plus Fracture Head Prosthesis cleared by the FDA?
Plus Fracture Head Prosthesis (K990309) received a 510(k) decision of Substantially Equivalent on March 15, 1999, 42 days after the submission was received.
What is the product code of K990309?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.