510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831792Substantially Equivalent

Self-Aligning Acetabular Component

Endomedics, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831792 is the FDA 510(k) clearance record for SELF-ALIGNING ACETABULAR COMPONENT, a class III device, cleared for Endomedics, Inc. on under FDA product code JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)). FDA records list 4 510(k) clearances for Endomedics, Inc., from to . As of , FDA records show no recalls naming K831792.

Clearance record

Decision date
Received
(475 days to decision)
Product code
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Regulation
21 CFR 888.3320
Device class
Class III
Review panel
Orthopedic
Applicant
Endomedics, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JDL

Trailing 12 months

FDA records hold no clearances under product code JDL in the trailing twelve months.

FDA records show no clearances under product code JDL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JDL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260