510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K110864Substantially Equivalent

Biospine Vbr System

Aesculap Inc, Center Valley PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110864 is the FDA 510(k) clearance record for BIOSPINE VBR SYSTEM, a class II device, cleared for Aesculap Implant Systems, LLC on under FDA product code MQP (Spinal Vertebral Body Replacement Device). FDA records list 269 510(k) clearances for AESCULAP, INC., from to . As of , FDA records show no recalls naming K110864.

Clearance record

Decision date
Received
(78 days to decision)
Product code
MQP Spinal Vertebral Body Replacement Device
Regulation
21 CFR 888.3060
Device class
Class II
Review panel
Orthopedic
Applicant
Aesculap Implant Systems, LLC 3773 Corporate Pkwy., Center Valley PA
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