510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960711Substantially Equivalent

Acumed Bone Graft System

Acu Med, Inc., Beaverton OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960711 is the FDA 510(k) clearance record for ACUMED BONE GRAFT SYSTEM, a class I device, cleared for Acu Med, Inc. on under FDA product code KIJ (Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment). FDA records list 48 510(k) clearances for Acu Med, Inc., from to . As of , FDA records show 2 recalls naming K960711.

Clearance record

Decision date
Received
(76 days to decision)
Product code
KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Acu Med, Inc. 10950 SW 5th St., Beaverton OR
510(k) summary
Summary
Third party review
No

Clearances, product code KIJ

Trailing 12 months

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

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