510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K112907Substantially Equivalent

Confidence High Viscosity Spinal Cement, 16G / 20G

Medos International SARL, Raynham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112907 is the FDA 510(k) clearance record for CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G, a class II device, cleared for Medos International SARL on under FDA product code NDN (Cement, Bone, Vertebroplasty). FDA records list 101 510(k) clearances for Medos International SARL, from to . As of , FDA records show no recalls naming K112907.

Clearance record

Decision date
Received
(80 days to decision)
Product code
NDN Cement, Bone, Vertebroplasty
Regulation
21 CFR 888.3027
Device class
Class II
Review panel
Orthopedic
Applicant
Medos International SARL 325 Paramount Dr., Raynham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NDN

Trailing 12 months
1 clearance under product code NDN in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NDN, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260