510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K014049Substantially Equivalent

Epoca Codr Stem and Head

Globus Medical, Inc., Pittsburgh PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K014049 is the FDA 510(k) clearance record for EPOCA CODR STEM AND HEAD, a class II device, cleared for Stelkast Company on under FDA product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented). FDA records list 217 510(k) clearances for GLOBUS MEDICAL, INC., from to . As of , FDA records show no recalls naming K014049.

Clearance record

Decision date
Received
(30 days to decision)
Product code
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Regulation
21 CFR 888.3650
Device class
Class II
Review panel
Orthopedic
Applicant
Stelkast Company 800 Vinial St. #210, Pittsburgh PA
510(k) summary
Statement
Third party review
No

Clearances, product code KWT

Trailing 12 months
2 clearances under product code KWT in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KWT, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260