Tri-Lock Modified Femoral Prosthesis
FDA 510(k) K872878 · Depuy, Inc.
510(k) numberK872878
Submission
- Device name
- Tri-Lock Modified Femoral Prosthesis
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- July 21, 1987
- Decision date
- August 7, 1987
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 Tri-Lock Modified Femoral Prosthesis cleared by the FDA?
Tri-Lock Modified Femoral Prosthesis (K872878) received a 510(k) decision of Substantially Equivalent for Some Indications on August 7, 1987, 17 days after the submission was received.
What is the product code of K872878?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.