Elevator
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
137 adverse event reports on file
- PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGEJul 9, 2026MalfunctionSynthes Gmbh8030965-2026-07004
- PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGEJun 29, 2026MalfunctionSynthes Gmbh8030965-2026-06707
- PERIOSTEAL ELEVATOR 6MM CURVED BLADEJun 12, 2026MalfunctionSynthes Gmbh8030965-2026-06153
- PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGEMar 18, 2026MalfunctionSynthes Gmbh8030965-2026-02597
- PERIOSTEAL ELEVATOR 14MM CURVED BLADE-ROUND EDGEMar 10, 2026MalfunctionSynthes Gmbh8030965-2026-02393
- ENDPLATE ELEVATORMar 9, 2026MalfunctionSynthes Gmbh8030965-2026-02316
- PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGEJan 29, 2026MalfunctionSynthes Gmbh8030965-2026-01023
- PERIOST-ELEV SLIGHTLY CURV-BLADE STRAIGHNov 11, 2025MalfunctionSynthes Gmbh8030965-2025-11282
- PERIOSTEAL ELEVATOR, STRAIGHT SHAFT, 14MM WIDE, L 200MMOct 24, 2025MalfunctionSynthes Gmbh8030965-2025-10686
- PERIOST-ELEV SLIGHTLY CURV-BLADE STRAIGHOct 15, 2025MalfunctionSynthes Gmbh8030965-2025-10430
Event type breakdown
Recalls
3 recall events for this product code
- SpineFrontier, Inc.TerminatedJan 16, 2014
Arena-L Trial Handle; Part: 11-81002
Handles and heads may not be compatible.
Z-0776-2014 · View FDA record ↗ - SpineFrontier, Inc.TerminatedJan 16, 2014
Arena-L 35x26 Trial Head I 10 Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16
Handles and heads may not be compatible.
Z-0777-2014 · View FDA record ↗ - SpineFrontier, Inc.TerminatedJan 16, 2014
Arena-L 38x28Trial Head I 10 Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14
Handles and heads may not be compatible.
Z-0778-2014 · View FDA record ↗
Registered firms
175 firms currently registered for this product code
4web Inc.
Frisco, TX, US
Micropulse Inc
Columbia City, IN, US
Asanus Medizintechnik Gmbh
NEUHAUSEN OBECK Baden-Wurttemberg, DE
Arch Medical Solutions - Memphis
BARTLETT, TN, US
Win Wings Corp.
SIALKOT Punjab, PK
Berger Surgical Medical Products Gmbh
Neuhausen ob Eck Baden-Wurttemberg, DE
Warsaw Orthopedic, Inc.
WARSAW, IN, US
Industrias Medicas Sampedro S.a.s
La Estrella Antioquia, CO
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Innomed, Inc.
SAVANNAH, GA, US
Fischer Surgical Inc.
Imperial, MO, US
Clariance, Inc.
Dallas, TX, US
Br Surgical Llc
Jacksonville, FL, US
Alphatec Spine, Inc.
Carlsbad, CA, US
Depuy Orthopaedics
BRIDGEWATER, MA, US
Power Dental Usa, Inc.
McHenry, IL, US
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Invidia Medical Gmbh U Co Kg
Emmingen-Liptingen Baden-Wurttemberg, DE
Post Surgical Mfg.
Hauppauge, NY, US
Acheron Instruments (pvt.) Ltd.
LAHORE Punjab, PK
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Miraclus Orthotech Private Limited
Ahmedabad Gujarat, IN
Microport Orthopedics Global Supply Center Limited
Shanghai, CN
Straits Orthopaedics (mfg) Sdn Bhd
Bandar Cassia Pulau Pinang, MY
Synthes (usa) Products Llc
West Chester, PA, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.