FDA.reportPublic FDA data

Internal spinal fixation procedure kit, reusable

Definition
A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a reusable device.
GUDID devices
2,888
Last updated
2026-11-01 02:54:41

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
G2308H1CH000320INTEGRATE-CHappe Spine, LLCInserter Handle DS2026-10-21
04056481001162CHISEL SHORT FOR OPEN SURGERYBrainlab SE55830-552016-09-15
04056481001179CHISEL LONG FOR OPEN SURGERYBrainlab SE55830-502016-09-15
04056481001193PROBE STRAIGHT (3.5 MM) FOR OPEN SURGERYBrainlab SE55830-432016-09-15
04056481001209PROBE STRAIGHT (4.5 MM) FOR OPEN SURGERYBrainlab SE55830-402016-09-15
04056481001216AWL (3.0 MM) FOR OPEN SURGERYBrainlab SE55830-35A2016-09-15
04056481001223AWL (4.0 MM) FOR OPEN SURGERYBrainlab SE55830-30A2016-09-15
00840185383495DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-08542026-09-29
00840185383501DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-08552026-09-29
00840185383518DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-08562026-09-29
00840185383525DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-08572026-09-29
00840185383532DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-08582026-09-29
00840185383549DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-08592026-09-29
00840185383556DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-08602026-09-29
00840185383563DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-08702026-09-29
00840185383570DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-08712026-09-29
00840185383587DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-08722026-09-29
00840185383594DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-08732026-09-29
00840185383600DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-08742026-09-29
00840185383617DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-08752026-09-29
00840185383624DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-08762026-09-29
G070SPX01505400000OneLIF™Novapproach Spine LLCSPX-015-054-00002026-09-29
00195377104779ORTHOPEDIC MANUAL SURGICAL INSTRUMENTGLOBUS MEDICAL, INC.42024102026-08-14
00195377104809ORTHOPEDIC MANUAL SURGICAL INSTRUMENTGLOBUS MEDICAL, INC.42024302026-08-14
00195377104816ORTHOPEDIC MANUAL SURGICAL INSTRUMENTGLOBUS MEDICAL, INC.42024402026-08-14
00195377104823ORTHOPEDIC MANUAL SURGICAL INSTRUMENTGLOBUS MEDICAL, INC.42024502026-08-14
00195377104830ORTHOPEDIC MANUAL SURGICAL INSTRUMENTGLOBUS MEDICAL, INC.42024602026-08-14
00195377104847ORTHOPEDIC MANUAL SURGICAL INSTRUMENTGLOBUS MEDICAL, INC.42024702026-08-14
00195377104854ORTHOPEDIC MANUAL SURGICAL INSTRUMENTGLOBUS MEDICAL, INC.42024802026-08-14
00195377104861ORTHOPEDIC MANUAL SURGICAL INSTRUMENTGLOBUS MEDICAL, INC.42024902026-08-14
00887517127693MaXcessNuvasive, Inc.70704222026-07-27
00887517413673MAS PLIFNuvasive, Inc.70700422026-04-25
00841732164185GENERIC Surgical InstrumentsCTL Medical Corporation50-6000-0012023-09-14
00841732164246GENERIC Surgical InstrumentsCTL Medical Corporation50-6000-0072023-09-15
03770019503416Drill - Screw D.3,5mm-L.18SC MEDICA58.F18.35S2026-07-03
03770019503867Cannulated Screwdriver tip for screw D3,5mm-L.16SC MEDICA58.E18.35S2026-07-03
00840283407949VyPlate™VY SPINE LLC06-IPH-0022026-06-05
00841732165236VALEO II LL Interbody Fusion SystemCTL Medical Corporation91.020.12002024-11-01
00197157058128ZAVATION INSTRUMENTZavation LLC1010-10002026-06-01
00197157058135ZAVATION INSTRUMENTZavation LLC1010-10032026-06-01
00197157058142ZAVATION INSTRUMENTZavation LLC1010-10042026-06-01
00197157058159ZAVATION INSTRUMENTZavation LLC1010-10052026-06-01
00197157058166ZAVATION INSTRUMENTZavation LLC1010-10062026-06-01
00197157058173ZAVATION INSTRUMENTZavation LLC1010-10092026-06-01
00197157058180ZAVATION INSTRUMENTZavation LLC1010-10082026-06-01
00197157058197ZAVATION INSTRUMENTZavation LLC1010-10072026-06-01
00197157058203ZAVATION INSTRUMENTZavation LLC1010-10102026-06-01
00197157058265ZAVATION INSTRUMENTZavation LLC1010-10152026-06-01
00197157069599ZAVATION INSTRUMENTZavation LLC10-10552026-06-01
00841732130036PICASSO II MIS Spinal SystemCTL Medical Corporation119.77712023-09-15
00841732131996PICASSO II MIS Spinal SystemCTL Medical Corporation119.70932023-09-15
00841732132009PICASSO II MIS Spinal SystemCTL Medical Corporation119.71002023-09-15
00841732134751PICASSO IICTL Medical Corporation119.70922023-09-15
00841732143999PICASSO IICTL Medical Corporation119.70842023-09-15
008401853273524CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-02142026-05-29
008401853273694CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01342026-05-29
008401853273764CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01052026-05-29
008401853273834CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01062026-05-29
008401853273904CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01072026-05-29
008401853274064CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01082026-05-29
008401853274134CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01092026-05-29
008401853274204CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01102026-05-29
008401853274374CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01112026-05-29
008401853274444CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01122026-05-29
008401853274514CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01232026-05-29
008401853274684CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01242026-05-29
008401853274754CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01252026-05-29
008401853274824CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01262026-05-29
008401853274994CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01272026-05-29
008401853275054CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01282026-05-29
008401853275124CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01292026-05-29
008401853275294CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01302026-05-29
008401853275364CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01332026-05-29
008401853275434CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01352026-05-29
008401853275504CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01712026-05-29
008401853275674CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01722026-05-29
008401853275744CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01732026-05-29
008401853275814CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01742026-05-29
008401853275984CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01752026-05-29
008401853276044CIS DOLPHIN TLIF CAGE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAIIN-0105-01762026-05-29