510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080873Substantially Equivalent

Opacity + Bone Cement

Teknimed SAS, Round Rock TX / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080873 is the FDA 510(k) clearance record for OPACITY + BONE CEMENT, a class II device, cleared for Teknimed, S.A. on under FDA product code NDN (Cement, Bone, Vertebroplasty). FDA records list 15 510(k) clearances for TEKNIMED SAS, from to . As of , FDA records show no recalls naming K080873.

Clearance record

Decision date
Received
(150 days to decision)
Product code
NDN Cement, Bone, Vertebroplasty
Regulation
21 CFR 888.3027
Device class
Class II
Review panel
Orthopedic
Applicant
Teknimed, S.A. 1001 Oakwood Blvd., Round Rock TX
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 October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NDN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260