510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K091946Substantially Equivalent

Vlift-S Vertebral Body Replacement System, Models 488812Xx, 488814Xx, 488816Xx, 488818Xx

Howmedica Osteonics Corp, Allendale NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091946 is the FDA 510(k) clearance record for VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX, a class II device, cleared for Stryker Spine on under FDA product code MQP (Spinal Vertebral Body Replacement Device). FDA records list 377 510(k) clearances for HOWMEDICA OSTEONICS CORP, from to . As of , FDA records show no recalls naming K091946.

Clearance record

Decision date
Received
(87 days to decision)
Product code
MQP Spinal Vertebral Body Replacement Device
Regulation
21 CFR 888.3060
Device class
Class II
Review panel
Orthopedic
Applicant
Stryker Spine 2 Pearl Ct., Allendale NJ
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 November 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MQP, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20262
August 20260
September 20260
October 20260
November 20260