FDA.reportPublic FDA data

Osteotomy compression/distraction instrument

Definition
A non-sterile manual surgical instrument intended to be used for compression and distraction of an osteotomy. It is comprised of two arms that attach to pins/screws/nails inserted into both sides of the cut bone, and includes a mechanism (e.g., screw) used to close and open the arms of the device enabling compression and distraction at the osteotomy line. This is a reusable device.
GUDID devices
45
Last updated
2026-03-09 19:08:29

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850080772980A8 INTEGR8® Porous Pedicle Screw SystemALLUMIN8, INC.A8NS-002-00052026-02-27
00850080774076A8 INTEGR8® Porous Pedicle Screw SystemALLUMIN8, INC.A8NS-002-00032026-02-27
00810152100462FUSIO™ SI Allograft SystemPROMETHEAN RESTORATIVE LLCCPS00172026-02-13
00810152101391FUSIO™ SI Allograft SystemPROMETHEAN RESTORATIVE LLCCPS00132026-02-13
00888480530817Telluride MIS Spinal Fixation SystemHighridge Medical, LLC7706-13012026-01-13
03662663217040Telluride MIS Spinal Fixation SystemHighridge Medical, LLC7706-12702026-01-13
03662663244718Vital MIS Spinal Fixation SystemHighridge Medical, LLC850M00582025-12-18
03662663198196Alpine XC Adjustable Fusion SystemHighridge Medical, LLC6330-11562025-12-17
03662663162326Zyston Interbody Spacer SystemHighridge Medical, LLC14-5351082025-12-16
03662663194143PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLC3569-12025-12-15
03662663195850Alpine XC Adjustable Fusion SystemHighridge Medical, LLC6200-11052025-12-15
03662663195867Alpine XC Adjustable Fusion SystemHighridge Medical, LLC6200-11062025-12-15
03662663195928Alpine XC Adjustable Fusion SystemHighridge Medical, LLC6200-11152025-12-15
03662663195935Alpine XC Adjustable Fusion SystemHighridge Medical, LLC6200-11252025-12-15
03662663195942Alpine XC Adjustable Fusion SystemHighridge Medical, LLC6200-11262025-12-15
03662663195959Alpine XC Adjustable Fusion SystemHighridge Medical, LLC6200-11282025-12-15
03662663195966Alpine XC Adjustable Fusion SystemHighridge Medical, LLC6200-11342025-12-15
03662663195973Alpine XC Adjustable Fusion SystemHighridge Medical, LLC6200-11352025-12-15
03662663195980Alpine XC Adjustable Fusion SystemHighridge Medical, LLC6200-11362025-12-15
03662663196000Alpine XC Adjustable Fusion SystemHighridge Medical, LLC6200-11492025-12-15
03662663196017Alpine XC Adjustable Fusion SystemHighridge Medical, LLC6200-11512025-12-15
03662663198189Alpine XC Adjustable Fusion SystemHighridge Medical, LLC6330-11552025-12-15
00888480484912Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLC14-5016702025-12-03
00888480484929Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLC14-5016712025-12-03
00888480484936Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLC14-5016722025-12-03
03662663113199Virage OCT Spinal Fixation SystemHighridge Medical, LLC07.01778.0012025-12-03
03662663125895Vital MIS Spinal Fixation SystemHighridge Medical, LLC07.02089.0012025-12-03
03662663136884Polaris 4.75 Deformity SystemHighridge Medical, LLC14-5100182025-12-03
03662663136891Polaris 4.75 Deformity SystemHighridge Medical, LLC14-5100192025-12-03
03662663153478Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLC14-5250272025-12-03
03662663154437Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLC14-5309832025-12-03
03662663154444Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLC14-5309842025-12-03
03662663154451Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLC14-5309852025-12-03
03662663154468Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLC14-5309862025-12-03
00810082893618Stratum AnkleMedartis Inc.SAJTSPRD2023-06-02
00810082898170Stratum AnkleMedartis Inc.SAJDSCREW2023-06-02
00195860005330Whistler Modular Pedicle Screw SystemEvolution Spine LLCSI-0122021-05-17
00195860005347Whistler Modular Pedicle Screw SystemEvolution Spine LLCSI-0132021-05-17
00083208130120Bone Molder - StraightSuncoast Dental, IncBone Molder - Straight2021-02-03
00083208130137Bone Molder - OffsetSuncoast Dental, IncBone Molder - Offset2021-02-03
00842188121166Tools - FPSTrimed, INC.COMPR-1.6/2.52020-01-20
00842188121173Tools - FPSTrimed, INC.DSTRCTR-1.6/2.52020-01-20
00842188121401Tools - FPSTrimed, INC.SPRDRLMN2020-01-20
00889795040787Baby Gorilla/Gorilla Plating SystemParagon 28, Inc.P99-150-00112019-10-17
00889795056665Baby Gorilla/Gorilla Plating SystemParagon 28, Inc.P99-150-0011-R2019-10-17