1
/
of
0
FDA 510(k), K160895, Initia Total Hip System & BIOCERAM AZUL(R) HEAD
FDA 510(k), K160895, Initia Total Hip System & BIOCERAM AZUL(R) HEAD
Regular price
$149.00 USD
Regular price
Sale price
$149.00 USD
Unit price
/
per
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: 03/31/2016
Date Received: 11/01/2016
Decision Date: 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: 03/31/2016
Date Received: 11/01/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Couldn't load pickup availability
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
View full details