Aml(R) Collarless Lateralized Femoral Hip
FDA 510(k) K891482 · Depuy, Inc.
510(k) numberK891482
Submission
- Device name
- Aml(R) Collarless Lateralized Femoral Hip
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- March 17, 1989
- Decision date
- May 16, 1989
- 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 Aml(R) Collarless Lateralized Femoral Hip cleared by the FDA?
Aml(R) Collarless Lateralized Femoral Hip (K891482) received a 510(k) decision of Substantially Equivalent for Some Indications on May 16, 1989, 60 days after the submission was received.
What is the product code of K891482?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.