510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990816Substantially Equivalent

Avcore System

Modular Cutting Systems, Inc., Bridgeport CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990816 is the FDA 510(k) clearance record for AVCORE SYSTEM, a class I device, cleared for Modular Cutting Systems, Inc. on under FDA product code HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment). FDA records list 2 510(k) clearances for Modular Cutting Systems, Inc., from to . As of , FDA records show no recalls naming K990816.

Clearance record

Decision date
Received
(197 days to decision)
Product code
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Modular Cutting Systems, Inc. 650 Clinton Ave., Bridgeport CT
510(k) summary
Summary
Third party review
No

Clearances, product code HWE

Trailing 12 months

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

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