510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912843Substantially Equivalent

Flexmedics Retract Orth Probe, Pettine Bone Probe

Flexmedics, Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912843 is the FDA 510(k) clearance record for FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE, a class I device, cleared for Flexmedics on under FDA product code HXB (Probe). FDA records list 20 510(k) clearances for Flexmedics, from to . As of , FDA records show no recalls naming K912843.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HXB Probe
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Flexmedics 620 Ford Ctr., 420 N. Fifth, Minneapolis MN
510(k) summary
Statement
Third party review
No

Clearances, product code HXB

Trailing 12 months

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

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