510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K110153Substantially Equivalent

Sfc Vertebral Body Replacement

Konigsee Implantate GmbH, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110153 is the FDA 510(k) clearance record for SFC VERTEBRAL BODY REPLACEMENT, a class II device, cleared for Konigsee Implantate GmbH on under FDA product code MQP (Spinal Vertebral Body Replacement Device). FDA records list one 510(k) clearance for Konigsee Implantate GmbH. As of , FDA records show no recalls naming K110153.

Clearance record

Decision date
Received
(266 days to decision)
Product code
MQP Spinal Vertebral Body Replacement Device
Regulation
21 CFR 888.3060
Device class
Class II
Review panel
Orthopedic
Applicant
Konigsee Implantate GmbH 1331 H St. NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQP

Trailing 12 months
3 clearances under product code MQP in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MQP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20262
August 20260
September 20260
October 20260