510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900405Substantially Equivalent

Scholten Frame

Scholten Surgical Instruments, Inc., Oakland CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900405 is the FDA 510(k) clearance record for SCHOLTEN FRAME, a class I device, cleared for Scholten Surgical Instruments, Inc. on under FDA product code JEB (Table, Surgical With Orthopedic Accessories, Manual). FDA records list 8 510(k) clearances for Scholten Surgical Instruments, Inc., from to . As of , FDA records show no recalls naming K900405.

Clearance record

Decision date
Received
(31 days to decision)
Product code
JEB Table, Surgical With Orthopedic Accessories, Manual
Regulation
21 CFR 878.4950
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Scholten Surgical Instruments, Inc. 100 Hegenberger Rd.,, Oakland CA
Third party review
No

Clearances, product code JEB

Trailing 12 months

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

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