Medical Device Manufacturer · US , Mountain View , CA

Oratec Interventions, Inc. - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 1995
24
Total
24
Cleared
0
Denied
FDA 510(k) Regulatory Record - Oratec Interventions, Inc. General & Plastic Surgery
21 devices
1-21 of 21
Cleared Jan 31, 2002
NUCLEOTOMY INTRADISCAL CATHETER
K013622 · GEI
General & Plastic Surgery · 87d
Cleared Feb 04, 2000
ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES)
K992805 · GEI
General & Plastic Surgery · 168d
Cleared Jan 18, 2000
ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES
K994333 · GEI
General & Plastic Surgery · 26d
Cleared Dec 17, 1999
ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002
K993967 · GEI
General & Plastic Surgery · 24d
Cleared Dec 06, 1999
ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES
K993854 · GEI
General & Plastic Surgery · 21d
Cleared Oct 25, 1999
ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND...
K991140 · GEI
General & Plastic Surgery · 203d
Cleared Sep 13, 1999
ORATEC BIPOLAR ABLATION PROBES
K991218 · GEI
General & Plastic Surgery · 154d
Cleared Jul 30, 1999
ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS,...
K992408 · GEI
General & Plastic Surgery · 10d
Cleared Jun 23, 1999
DEFLECTABLE ELECTROSURGICAL PROBES
K991190 · GEI
General & Plastic Surgery · 76d
Cleared Jun 14, 1999
DEFLECTABLE TAC ELECTROTHERMAL PROBE
K990859 · GEI
General & Plastic Surgery · 90d
Cleared May 17, 1999
ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE SYSTEM AND...
K990474 · GEI
General & Plastic Surgery · 90d
Cleared Dec 16, 1998
MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY
K984185 · GEI
General & Plastic Surgery · 23d
Cleared Nov 23, 1998
ORATEC TAC-C, MONOPOLAR CAUTERY PROBE
K982971 · GEI
General & Plastic Surgery · 90d
Cleared Mar 19, 1998
ORATEC SPINECATH INTRADISCAL CATHETER
K974464 · GEI
General & Plastic Surgery · 113d
Cleared Jan 23, 1998
ORATEC MODEL ENDOTAC PROBE
K972358 · GEI
General & Plastic Surgery · 212d
Cleared Nov 05, 1997
ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE
K973158 · GEI
General & Plastic Surgery · 75d
Cleared Sep 25, 1997
ORATEC INTERVENTIONS MODEL ORA 40 ELECTROTHERMAL GENERATOR
K973159 · GEI
General & Plastic Surgery · 34d
Cleared Feb 06, 1997
ORATEC INTERVENTIOUNS ELECTROSURGICAL PROBES
K965007 · GEI
General & Plastic Surgery · 52d
Cleared Dec 12, 1996
ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOR
K964071 · GEI
General & Plastic Surgery · 62d
Cleared Sep 18, 1996
ORATEC INTERVENTIONS MODEL TAC-S MONOPOLAR CAUTERY PROBE (MODIFY)
K963157 · GEI
General & Plastic Surgery · 55d
Cleared Dec 18, 1995
ORATEC INTERVENTIONS MODEL TAC 1000 MONOPOLAR CAUTERY PROBE
K954439 · GEI
General & Plastic Surgery · 84d
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