510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082468Substantially Equivalent

Apex Hip System Bipolar Head, Model H3-822Xx and H3-828Yy, Xx=od in [Mm] (38-43), Yy=od in [Mm](44-60)

Omni Life Science, Inc., Raynham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082468 is the FDA 510(k) clearance record for APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60), a class II device, cleared for Omni Life Science, Inc. on under FDA product code KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented). FDA records list 28 510(k) clearances for Omni Life Science, Inc., from to . As of , FDA records show 23 recalls naming K082468.

Clearance record

Decision date
Received
(175 days to decision)
Product code
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Regulation
21 CFR 888.3390
Device class
Class II
Review panel
Orthopedic
Applicant
Omni Life Science, Inc. 175 Paramount Dr., Raynham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWY

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