510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820813Substantially Equivalent

Lesser Metatarsal Phalang. Joint Prosth

Sutter Biomedical, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820813 is the FDA 510(k) clearance record for LESSER METATARSAL PHALANG. JOINT PROSTH, a class II device, cleared for Sutter Biomedical, Inc. on under FDA product code KWH (Prosthesis, Toe, Constrained, Polymer). FDA records list 11 510(k) clearances for Sutter Biomedical, Inc., from to . As of , FDA records show no recalls naming K820813.

Clearance record

Decision date
Received
(59 days to decision)
Product code
KWH Prosthesis, Toe, Constrained, Polymer
Regulation
21 CFR 888.3720
Device class
Class II
Review panel
Orthopedic
Applicant
Sutter Biomedical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KWH

Trailing 12 months

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

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