Osteotome, Manual
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
61 adverse event reports on file
- LAMBOTTE OSTEOTOME CVD 1/4Jun 10, 2026MalfunctionIntegra Lifesciences Mansfield3014334038-2026-00047
- JARIT 1/4 OSTEOTOMEMay 13, 2026InjuryJarit GmbhMW5188148
- KMEDIC LAMBOTTE OSTEOTOMEMar 30, 2026InjuryTeleflex Llc (nadc)MW5186078
- JARIT LAMBOTTE OSTEOTOME 3/4"Oct 9, 2025InjuryIntegra Lifesciences CorporationMW5177134
- LAMBOTTE OSTEOTOME STR 20MM 240MMOct 8, 2025InjuryAesculap Ag9610612-2025-00249
- LAMBOTTE OSTEOTOME STR 15MM 240MMOct 8, 2025InjuryAesculap Ag9610612-2025-00253
- LAMBOTTE OSTEOTOME STR 13MM 240MMOct 8, 2025InjuryAesculap Ag9610612-2025-00250
- PIEZOTOME M+ ROUNDED ANGLED LEFT SAW TIPAug 1, 2023MalfunctionMarina Medical Instruments, Inc.17434220
- PIEZOTOME M+ ROUNDED ANGLED LEFT SAW TIPAug 1, 2023MalfunctionMarina Medical Instruments, Inc.17434989
- LAMBOTTE OSTEOTOME STR 15MM 240MMJun 26, 2020MalfunctionAesculap Ag9610612-2020-00247
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
143 firms currently registered for this product code
Microport Orthopedics Global Supply Center Limited
Shanghai, CN
Phillips Precision Inc
Elmwood Park, NJ, US
Stengelin Medical Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Rti Surgical, Inc. (dba Rti Biologics, Inc.)
ALACHUA, FL, US
Rsb Spine Llc.
Wooster, OH, US
Mian Shahid Corp.
MUZAFFAR PUR, SIALKOT Punjab, PK
Bauer Und Haselbarth-chirurg Gmbh
ELLERAU Schleswig-Holstein, DE
Avilign Medical
Sialkot Punjab, PK
Instrumed International Inc Dba Avalign German Specialty Instruments
SCHAUMBURG, IL, US
Teleflex Medical Llc
Morrisville, NC, US
Ambler Surgical, Llc
EXTON, PA, US
Manman Manufacturing Company Private Limited
Pune Maharashtra, IN
Aesculap, Inc.
CENTER VALLEY, PA, US
Invidia Medical Gmbh U Co Kg
Emmingen-Liptingen Baden-Wurttemberg, DE
Rz Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Teleflex Llc (nadc)
Olive Branch, MS, US
George Tiemann & Co.
HAUPPAUGE, NY, US
Hu-friedy Mfg.co. Llc Zweigniederlassung Deutsc
Emmingen-Liptingen Baden-Wurttemberg, DE
Tecomet, Inc.
KENOSHA, WI, US
Lenox-maclaren Surgical Corp.
LOUISVILLE, CO, US
Aspen Surgical Products, Inc.
Caledonia, MI, US
Bausch & Lomb Incorporated
Manchester, MO, US
Surgical Direct, Inc.
Orange City, FL, US
Pacific Instruments Inc.
Honolulu, HI, US
Arch - Quakertown
QUAKERTOWN, PA, US
510(k) clearances
6 clearances for this product code
- Valleylab, Inc.Nov 2, 1993
K933181 · VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500
- Innovative Surgical, Inc.Aug 19, 1993
K932534 · ISI FENESTRATED DISSECTING AND GRASPING FORCEPS
- Biomerieux Vitek, Inc.Sep 25, 1992
K920001 · HEMOLAB SILIMAT REAGENT
- Zinnanti Surgical Instruments, Inc.Apr 12, 1989
K891887 · OSTEOTOMES, VARIOUS TYPES
- Storz Instrument Co.Jul 11, 1985
K852541 · STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS
- Cher Mel Corp.Aug 2, 1984
K842823 · CHERMEL OSTEOTOMES