FDA.reportPublic FDA data

Orthopaedic implant inserter/extractor, single-use

Definition
A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a single-use device.
GUDID devices
233
Last updated
2024-08-29 07:13:13

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B756STR00107SP1Shukla Trephine S9TREPHINEShukla MedicalSTR001-07-SP2024-08-21
B756STR00108SP1Shukla Trephine S9TREPHINEShukla MedicalSTR001-08-SP2024-08-21
B756STR00109SP1Shukla Trephine S9TREPHINEShukla MedicalSTR001-09-SP2024-08-21
B756STR00110SP1Shukla Trephine S9TREPHINEShukla MedicalSTR001-10-SP2024-08-21
B756STR00111SP0Shukla Trephine S9TREPHINEShukla MedicalSTR001-11-SP2024-08-21
B756STR00112SP1Shukla Trephine S9TREPHINEShukla MedicalSTR001-12-SP2024-08-21
B756STR00113SP1Shukla Trephine S9TREPHINEShukla MedicalSTR001-13-SP2024-08-21
B756STR00114SP1Shukla Trephine S9TREPHINEShukla MedicalSTR001-14-SP2024-08-21
B756STR00115SP1Shukla Trephine S9TREPHINEShukla MedicalSTR001-15-SP2024-08-21
B756STR00116SP0Shukla Trephine S9TREPHINEShukla MedicalSTR001-16-SP2024-08-21
B756STR00117SP1Shukla Trephine S9TREPHINEShukla MedicalSTR001-17-SP2024-08-21
B756STR00118SP1Shukla Trephine S9TREPHINEShukla MedicalSTR001-18-SP2024-08-21
B756STR00119SP1Shukla Trephine S9TREPHINEShukla MedicalSTR001-19-SP2024-08-21
B756STR00120SP1Shukla Trephine S9TREPHINEShukla MedicalSTR001-20-SP2024-08-21
B756STR00121SP1Shukla Trephine S9TREPHINEShukla MedicalSTR001-21-SP2024-08-21
B756STR00122SP1Shukla Trephine S9TREPHINEShukla MedicalSTR001-22-SP2024-08-21
B756STR00123SP1Shukla Trephine S9TREPHINEShukla MedicalSTR001-23-SP2024-08-21
B756STR00124SP1Shukla Trephine S9TREPHINEShukla MedicalSTR001-24-SP2024-08-21
B756STR00125SP1Shukla Trephine S9TREPHINEShukla MedicalSTR001-25-SP2024-08-21
B756STR00126SP1Shukla Trephine S9TREPHINEShukla MedicalSTR001-26-SP2024-08-21
SBLDACE050SP1Shukla Acetabular Cup - S9CUPShukla MedicalSBLDACE-50-SP2024-08-20
SBLDACE42SP1Shukla Acetabular Cup - S9CUPShukla MedicalSBLDACE-42-SP2024-08-20
SBLDACE44SP1Shukla Acetabular Cup - S9CUPShukla MedicalSBLDACE-44-SP2024-08-20
SBLDACE46SP1Shukla Acetabular Cup - S9CUPShukla MedicalSBLDACE-46-SP2024-08-20
SBLDACE48SP1Shukla Acetabular Cup - S9CUPShukla MedicalSBLDACE-48-SP2024-08-20
SBLDACE52SP1Shukla Acetabular Cup - S9CUPShukla MedicalSBLDACE-52-SP2024-08-20
SBLDACE54SP1Shukla Acetabular Cup - S9CUPShukla MedicalSBLDACE-54-SP2024-08-20
SBLDACE56SP1Shukla Acetabular Cup - S9CUPShukla MedicalSBLDACE-56-SP2024-08-20
SBLDACE58SP1Shukla Acetabular Cup - S9CUPShukla MedicalSBLDACE-58-SP2024-08-20
SBLDACE60SP1Shukla Acetabular Cup - S9CUPShukla MedicalSBLDACE-60-SP2024-08-20
SBLDACE62SP1Shukla Acetabular Cup - S9CUPShukla MedicalSBLDACE-62-SP2024-08-20
SBLDACE64SP1Shukla Acetabular Cup - S9CUPShukla MedicalSBLDACE-64-SP2024-08-20
SBLDACE66SP1Shukla Acetabular Cup - S9CUPShukla MedicalSBLDACE-66-SP2024-08-20
SBLDACE68SP1Shukla Acetabular Cup - S9CUPShukla MedicalSBLDACE-68-SP2024-08-20
SBLDACE70SP1Shukla Acetabular Cup - S9CUPShukla MedicalSBLDACE-70-SP2024-08-20
B756STR00106SP1Shukla Trephine S9TREPHINEShukla MedicalSTR001-06-SP2024-08-12
00840194478410Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.01-9200-10152024-08-07
00840194478427Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.01-9200-10202024-08-07
00840194478434Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.01-9200-10252024-08-07
00840194478441Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.01-9200-10302024-08-07
00840194478458Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.01-9200-10352024-08-07
00840194478465Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.01-9200-10402024-08-07
00840194478472Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.01-9200-10452024-08-07
00840194478489Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.01-9200-10502024-08-07
00840194478496Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.01-9200-10552024-08-07
00840194480246Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.01-9200-02012024-08-07
00840194480253Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.01-9200-02022024-08-07
00840194480260Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.01-9200-02032024-08-07
00840194480277Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.01-9200-02042024-08-07
00840194480284Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.01-9200-02052024-08-07
00840194480291Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.01-9200-02062024-08-07
00840118121958Flower OrthopedicsFLOWER ORTHOPEDICS CORPORATIONPERLG2024-04-02
00889795130686Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.P31-958-20012024-02-26
00889795130693Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.P31-958-00022024-02-26
00889795130709Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.P31-958-00032024-02-26
00889795130723Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.P31-958-00042024-02-26
00889795130730Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.P31-958-00052024-02-26
00889795130792Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.P31-958-00102024-02-26
00889795130808Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.P31-958-00202024-02-26
00889795130815Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.P31-958-00302024-02-26
05391527772804ReActiv8 Release ToolMAINSTAY MEDICAL LIMITEDEXT12024-01-22
00196449002429RIPTIDETyber Medical, LLC6ZBC000002023-11-17
00196449002436RIPTIDETyber Medical, LLC6ZBE000002023-11-17
00196449010073RIPTIDETyber Medical, LLC6ZB0000122023-11-17
M06760001180Integrity Delivery Instrument, Bone StapleAnika Therapeutics, Inc.60001182023-11-14
10603295552611INHANCEDEPUY (IRELAND)7505-10-1032023-11-08
00885556818770Surgical InstrumentsSmith & Nephew, Inc.119582ND2023-10-16
00885556818794Surgical InstrumentsSmith & Nephew, Inc.119592ND2023-10-16
00842188127625Tools-INSTrimed, INC.RMVIMN-3.0/3.62023-09-28
07540194012982FASSIER-DUVAL TELESCOPIC IM SYSTEMOrthopediatrics Canada ULCFRT2402023-08-08
07540194013040FASSIER-DUVAL TELESCOPIC IM SYSTEMOrthopediatrics Canada ULCFRT2502023-08-08
00190376477619InvictusALPHATEC SPINE, INC.179122023-03-11
00190376477626InvictusALPHATEC SPINE, INC.179132023-03-11
00190376477633InvictusALPHATEC SPINE, INC.179142023-03-11
00817701028789InCore SubtalarMedartis Inc.ICSUB80PDD2023-02-07
00817701028796InCore SubtalarMedartis Inc.ICSUBT25D2023-02-07
00840118121927Flex-Thread UlnaFLOWER ORTHOPEDICS CORPORATION8813-12023-02-07
00840118122955Flex-Thread UlnaFLOWER ORTHOPEDICS CORPORATION8815-12023-02-07
00817701026464Nextra CHMedartis Inc.CH-RTR2020-11-11
07290019087045Agili-C Mini Disposable ToolsetCARTIHEAL (2009) LTDMINI-DS2022-10-04