FDA Device Intelligence
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Spinal Vertebral Body Replacement Device

FDA product code MQP · Class 2 · Orthopedic

34,616
Registered devices
2,950
Adverse events
46
Recalls
279
510(k) clearances

Devices with this code

TETRIS 4° — SIGNUS Medizintechnik GmbHCONSTRUX -PEEK VBR — Orthofix US LLCPILLAR SA — Orthofix US LLCOmnia Medical VBR — OMNIA MEDICAL, LLCCoRoent — Nuvasive, Inc.Ascend — ALPHATEC SPINE, INC.HONOUR™ Spacer System — NEXXT SPINE, LLCCONTACT™* IBF PEEK VBR/IBF SYSTEM — Pioneer Surgical Technology, Inc.T2 STRATOSPHERE™ Expandable Corpectomy System — MEDTRONIC SOFAMOR DANEK, INC.CAPRI Corpectomy Cage System — VB Spine LLCALEUTIAN® Interbody Systems — VB Spine LLCCAPRI™ Corpectomy Cage System — VB Spine LLCApache — Genesys Orthopedics Systems LLCPEEK SPACER WITH X-RAY MARKERS — BIOMET SPINE LLCCONSTRUX - PEEK VBR — Orthofix US LLCPEEK Interbody Fusion System — Altus Spine, LLCVERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.HONOUR™ Spacer System — NEXXT SPINE, LLCHONOUR™ Spacer System — NEXXT SPINE, LLCHONOUR™ Spacer System — NEXXT SPINE, LLCTimberline® MPF Lateral Interbody Modular Plate Fixation System — BIOMET SPINE LLCobelisc™ vertebral body replacement — Ulrich GmbH & Co. KGTIMBERLINE LATERAL FUSION SYSTEM — BIOMET SPINE LLCHONOUR™ Spacer System — NEXXT SPINE, LLC

Recent recalls

DateFirmReason
2022-11-10NuVasive IncPotential that insert will be unable to disengage from the vertebral body replacement device/implant
2020-09-21Synthes (USA) Products LLCIncorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21Synthes (USA) Products LLCIncorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21Synthes (USA) Products LLCIncorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21Synthes (USA) Products LLCIncorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21Synthes (USA) Products LLCIncorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21Synthes (USA) Products LLCIncorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21Synthes (USA) Products LLCIncorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21Synthes (USA) Products LLCIncorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
2020-09-21Synthes (USA) Products LLCIncorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.