510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K994364Substantially Equivalent

Synthes Button Plate

Synthes (USA) Products LLC, Paoli PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994364 is the FDA 510(k) clearance record for SYNTHES BUTTON PLATE, a class II device, cleared for Synthes (Usa) on under FDA product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show one recall naming K994364.

Clearance record

Decision date
Received
(79 days to decision)
Product code
MBI Fastener, Fixation, Nondegradable, Soft Tissue
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Synthes (Usa) 1690 Russell Rd., Paoli PA
510(k) summary
Summary
Third party review
No

Clearances, product code MBI

Trailing 12 months
31 clearances under product code MBI in the twelve months to October 2026, March 2026 the highest month at 9.
Show the numbers
Monthly 510(k) clearances under FDA product code MBI, trailing twelve months
MonthClearances
November 20251
December 20252
January 20263
February 20261
March 20269
April 20261
May 20264
June 20261
July 20264
August 20262
September 20263
October 20260