Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners
FDA 510(k) K173583 · Exactech, Inc.
Submission
- Device name
- Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners
- Applicant
- Exactech, Inc.
Gainesville, FL, US - Received
- November 20, 2017
- Decision date
- March 12, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OQI – Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3353
- Specialty
- Orthopedic
- Implant
- Yes
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and…
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Questions and answers
When was Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners cleared by the FDA?
Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners (K173583) received a 510(k) decision of Substantially Equivalent on March 12, 2018, 112 days after the submission was received.
What is the product code of K173583?
The FDA product code is OQI – Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3353.