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FDA 510(k), K133386, OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM
FDA 510(k), K133386, OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM
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510(K) Number: K133386
Device Name: OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM
Manufacturer: MIKE ENSIGN
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation Number: LPH
Classification Product Code: 11/05/2013
Date Received: 03/11/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM
Manufacturer: MIKE ENSIGN
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation Number: LPH
Classification Product Code: 11/05/2013
Date Received: 03/11/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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