510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950998Substantially Equivalent

Moduilar Unipolar

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

K950998 is the FDA 510(k) clearance record for MODUILAR UNIPOLAR, a class II device, cleared for Intermedics Orthopedics on under FDA product code KXA (Prosthesis, Hip, Femoral, Resurfacing). FDA records list 108 510(k) clearances for Intermedics Orthopedics, from to . As of , FDA records show no recalls naming K950998.

Clearance record

Decision date
Received
(41 days to decision)
Product code
KXA Prosthesis, Hip, Femoral, Resurfacing
Regulation
21 CFR 888.3400
Device class
Class II
Review panel
Orthopedic
Applicant
Intermedics Orthopedics 1300-C E. Anderson Ln., Austin TX
510(k) summary
Summary
Third party review
No

Clearances, product code KXA

Trailing 12 months

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

FDA records show no clearances under product code KXA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KXA, 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