510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991590Substantially Equivalent

C-Leg (3C100)

Otto Bock Orthopedic Industry, Inc., Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991590 is the FDA 510(k) clearance record for C-LEG (3C100), a class II device, cleared for Otto Bock Orthopedic Industry, Inc. on under FDA product code ISW (Assembly, Knee/Shank/Ankle/Foot, External). FDA records list 6 510(k) clearances for Otto Bock Orthopedic Industry, Inc., from to . As of , FDA records show one recall naming K991590.

Clearance record

Decision date
Received
(62 days to decision)
Product code
ISW Assembly, Knee/Shank/Ankle/Foot, External
Regulation
21 CFR 890.3500
Device class
Class II
Review panel
Physical Medicine
Applicant
Otto Bock Orthopedic Industry, Inc. 3000 Xenium Ln., Suite N, Plymouth MN
510(k) summary
Summary
Third party review
No

Clearances, product code ISW

Trailing 12 months

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

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