510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K093477Substantially Equivalent

Shield Kyphoplasty System

Soteira, Inc., Ayer MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093477 is the FDA 510(k) clearance record for SHIELD KYPHOPLASTY SYSTEM, a class II device, cleared for Soteira, Inc. on under FDA product code NDN (Cement, Bone, Vertebroplasty). FDA records list one 510(k) clearance for Soteira, Inc. As of , FDA records show no recalls naming K093477.

Clearance record

Decision date
Received
(759 days to decision)
Product code
NDN Cement, Bone, Vertebroplasty
Regulation
21 CFR 888.3027
Device class
Class II
Review panel
Orthopedic
Applicant
Soteira, Inc. 5 Whitcomb Ave., Ayer 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 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