510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070293Substantially Equivalent

Benvenue Vcf Osteo Coil System

Benvenue Medical, Inc., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070293 is the FDA 510(k) clearance record for BENVENUE VCF OSTEO COIL SYSTEM, a class I device, cleared for Benvenue Medical, Inc. on under FDA product code OCJ (Spinal Channeling Instrument, Vertebroplasty). FDA's definition for product code OCJ reads: "Create channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA) prior to a vertebroplasty procedure. Treatment of pathological compression fractures of the vertebral body that may result from...". FDA records list 8 510(k) clearances for Benvenue Medical, Inc., from to . As of , FDA records show no recalls naming K070293.

Clearance record

Decision date
Received
(160 days to decision)
Product code
OCJ Spinal Channeling Instrument, Vertebroplasty
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Benvenue Medical, Inc. 1235 Pear Ave., #111, Mountain View CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OCJ

Trailing 12 months

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

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