510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914715Substantially Equivalent

Paralleling Guides

Implant Corp. of America, St. Petersburg FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914715 is the FDA 510(k) clearance record for PARALLELING GUIDES, a class I device, cleared for Implant Corp. of America on under FDA product code FZX (Guide, Surgical, Instrument). FDA records list 3 510(k) clearances for Implant Corp. of America, from to . As of , FDA records show no recalls naming K914715.

Clearance record

Decision date
Received
(852 days to decision)
Product code
FZX Guide, Surgical, Instrument
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Implant Corp. of America 2299 9th Ave. N., Suite 1-E, St. Petersburg FL
510(k) summary
Statement
Third party review
No

Clearances, product code FZX

Trailing 12 months

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

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