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FDA 510(k), K160895, Initia Total Hip System & BIOCERAM AZUL(R) HEAD
FDA 510(k), K160895, Initia Total Hip System & BIOCERAM AZUL(R) HEAD
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510(K) Number: K160895
Device Name: Initia Total Hip System & BIOCERAM AZUL(R) HEAD
Manufacturer: Cheryl Hastings
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Regulation Number: LZO
Classification Product Code: KXA
Date Received: 03/31/2016
Decision Date: 11/01/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: Initia Total Hip System & BIOCERAM AZUL(R) HEAD
Manufacturer: Cheryl Hastings
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Regulation Number: LZO
Classification Product Code: KXA
Date Received: 03/31/2016
Decision Date: 11/01/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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