510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960647Substantially Equivalent

Omega Total Hip System for Cemented Applications

Osteoimplant Technology, Inc., Hunt Valley MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960647 is the FDA 510(k) clearance record for OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS, a class II device, cleared for Osteoimplant Technology, Inc. on under FDA product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented). FDA records list 21 510(k) clearances for Osteoimplant Technology, Inc., from to . As of , FDA records show no recalls naming K960647.

Clearance record

Decision date
Received
(215 days to decision)
Product code
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Regulation
21 CFR 888.3350
Device class
Class II
Review panel
Orthopedic
Applicant
Osteoimplant Technology, Inc. 11201 Pepper Rd., Hunt Valley MD
510(k) summary
Statement
Third party review
No

Clearances, product code JDI

Trailing 12 months
3 clearances under product code JDI in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JDI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260