510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K111069Substantially Equivalent

Osteosymbionics, St Temporalis Implant

Osteosymbionics, LLC, Stillwater MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111069 is the FDA 510(k) clearance record for OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT, a class II device, cleared for Osteosymbionics, LLC on under FDA product code MNF (Implant, Temporal). FDA records list 4 510(k) clearances for Osteosymbionics, LLC, from to . As of , FDA records show no recalls naming K111069.

Clearance record

Decision date
Received
(157 days to decision)
Product code
MNF Implant, Temporal
Regulation
21 CFR 878.3550
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Osteosymbionics, LLC P.O. Box 560, Stillwater MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MNF

Trailing 12 months

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

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