510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983814Substantially Equivalent

Gotfried Percutaneous Compression Plating System

Efratgo, Ltd. HI Tech Bio-Surgical, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983814 is the FDA 510(k) clearance record for GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM, a class II device, cleared for Efratgo, Ltd. HI Tech Bio-Surgical on under FDA product code JDO (Device, Fixation, Proximal Femoral, Implant). FDA records list 3 510(k) clearances for Efratgo, Ltd. HI Tech Bio-Surgical, from to . As of , FDA records show no recalls naming K983814.

Clearance record

Decision date
Received
(78 days to decision)
Product code
JDO Device, Fixation, Proximal Femoral, Implant
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Efratgo, Ltd. HI Tech Bio-Surgical 555 Thirteenth St. NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code JDO

Trailing 12 months

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

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