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510(k) K153398

Comprehensive SRS/Nexel Elbow by Biomet Manufacturing Corp — Product Code JDC

K153398 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing Corp for the device "Comprehensive SRS/Nexel Elbow". The FDA issued a decision of Substantially Equivalent on February 3, 2016. The device falls under product code JDC (Prosthesis, Elbow, Constrained, Cemented), a Class II device regulated under 21 CFR 888.3150. Biomet Manufacturing Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2016
Date Received
November 24, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Constrained, Cemented
Device Class
Class II
Regulation Number
888.3150
Review Panel
OR
Submission Type

Other clearances by Biomet Manufacturing Corp

  • K230540 — Patient Specific Planning Solution™ 3D Bone Models (July 25, 2023)
  • K214001 — Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System (March 15, 2023)
  • K211729 — Comprehensive® Convertible Glenoid - Vivacit-E Liner (November 4, 2021)
  • K202232 — Comprehensive Vault Reconstruction System (February 19, 2021)
  • K193038 — Comprehensive Shoulder System (October 28, 2020)
  • K182516 — Comprehensive Nano Stemless Shoulder (April 22, 2019)
  • K181611 — Comprehensive Reverse Shoulder System (September 24, 2018)
  • K173411 — Comprehensive Segmental Revision System (SRS) (February 8, 2018)
  • K172502 — Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Co (January 3, 2018)
  • K163651 — ExpressBraid Graft Manipulation (February 17, 2017)

Other clearances for product code JDC

  • K181362 — TEMA Elbow System (February 16, 2019)
  • K181307 — Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow (January 28, 2019)
  • K150501 — Zimmer Nexel Total Elbow Ulnar Cement Diverter (April 23, 2015)
  • K123862 — ZIMMER NEXEL TOTAL ELBOW (March 12, 2013)
  • K090473 — DISCOVERY ELBOW - X-SMALL (March 25, 2009)
  • K060696 — ACCLAIM TOTAL ELBOW SYSTEM (April 14, 2006)
  • K053189 — COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES (December 9, 2005)
  • K051975 — POROUS COATED DISCOVERY ELBOW (September 6, 2005)
  • K042664 — LPS UPPER EXTREMITY (December 8, 2004)
  • K040389 — COONRAD/MORREY ELBOW CEMENT RESTRICTOR (May 17, 2004)

FDA data resources