510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K993027Substantially Equivalent

Eska Modular Hip System

Specs USA, Inc., Sarasota FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993027 is the FDA 510(k) clearance record for ESKA MODULAR HIP SYSTEM, a class II device, cleared for Specs USA, Inc. on under FDA product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented). FDA records list 2 510(k) clearances for Specs USA, Inc., from to . As of , FDA records show no recalls naming K993027.

Clearance record

Decision date
Received
(210 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
Specs USA, Inc. 635 S. Orange Ave., Sarasota FL
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