510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983509Substantially Equivalent

Inter-Op Acetabular System - Durasul Acetabular Insert

Sulzer Orthopedics, Inc., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983509 is the FDA 510(k) clearance record for INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT, a class II device, cleared for Sulzer Orthopedics, Inc. on under FDA product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented). FDA records list 45 510(k) clearances for Sulzer Orthopedics, Inc., from to . As of , FDA records show no recalls naming K983509.

Clearance record

Decision date
Received
(119 days to decision)
Product code
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation
21 CFR 888.3358
Device class
Class II
Review panel
Orthopedic
Applicant
Sulzer Orthopedics, Inc. 9900 Spectrum Dr., Austin TX
510(k) summary
Summary
Third party review
No

Clearances, product code LPH

Trailing 12 months
11 clearances under product code LPH in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LPH, trailing twelve months
MonthClearances
November 20252
December 20251
January 20261
February 20261
March 20260
April 20260
May 20261
June 20261
July 20261
August 20262
September 20261
October 20260