FDA.reportPublic FDA data

Orthopaedic implantation sleeve, reusable

Definition
A hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.
GUDID devices
3,317
Last updated
2026-10-04 01:42:05

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07613327007039ES2 SPINAL SYSTEMStryker Corporation482801002019-11-08
07613327264715XIA 4.5 EVOLUTIONStryker Corporation481380122019-11-08
07613327266351ES2 SPINAL SYSTEMStryker Corporation482800962019-11-08
07613327266573MANTISStryker Corporation482813152019-11-08
07613327271614OASYSStryker Corporation485619142019-11-08
07613327271638OASYSStryker Corporation485619152019-11-08
07613327274172AVS Anchor-L Lumbar Cage SystemStryker Corporation489900062019-11-08
07613327275827RADIUSStryker Corporation4866190502019-11-08
07613327275858RADIUSStryker Corporation4866190542019-11-08
07613327275872RADIUSStryker Corporation4866190512019-11-08
07613327276657XIA 3Stryker Corporation48231330S2019-11-08
07613327276787REFLEX HYBRIDStryker Corporation48511655V2019-11-08
07613327276794REFLEX HYBRIDStryker Corporation48511655F2019-11-08
07613327276824Reflex HybridStryker Corporation48511815A2019-11-08
07613327276893AVIATORStryker Corporation48770655V2019-11-08
07613327276923AVIATORStryker Corporation48770655F2019-11-08
07613327356649Xia 3 System - SerratoStryker Corporation482680122017-07-11
07613327356670Xia 3 System - SerratoStryker Corporation48268012S2017-07-11
10888857052994MESA Small Stature Spinal SystemVB Spine LLC3001-900952022-08-06
10888857103962EVEREST Spinal SystemVB Spine LLC5101-900082022-08-09
10888857103979EVEREST Spinal SystemVB Spine LLC5101-900092022-08-09
10888857261198EVEREST Spinal SystemVB Spine LLC5101-901172022-08-09
10888857261204EVEREST Spinal SystemVB Spine LLC5101-901672022-08-09
10888857261211EVEREST Spinal SystemVB Spine LLC5101-901682022-08-09
10888857261235EVEREST Spinal SystemVB Spine LLC5101-901702022-08-09
10888857261259EVEREST Spinal SystemVB Spine LLC5101-901712022-08-09
10888857325968EVEREST Spinal SystemVB Spine LLC5101-902182022-08-09
10888857381773EVEREST Spinal SystemVB Spine LLC5101-902512022-08-09
10888857433564NIAGARA® Lateral Access SystemVB Spine LLCAC01-900092020-06-10
10888857433571NIAGARA® Lateral Access SystemVB Spine LLCAC01-900102020-06-10
10888857551442NAPA Access SystemVB Spine LLC8030-901842024-01-04
10888857551459NAPA Access SystemVB Spine LLC8030-901852024-01-04
00889024711280Jgrknt Reusable Fishmouth Perc GuideBiomet Orthopedics, LLCSSI0086622026-08-25
00889024712034Percutaneous Soft Anchor Short 1.4mm GuideBiomet Orthopedics, LLCSSI0086612026-08-25
10886982193810NASynthes GmbH351.282017-02-20
10886982195159NASynthes GmbH355.702017-02-20
10886982196651NASynthes GmbH357.822017-02-20
10886982196668NASynthes GmbH357.902017-02-20
04099797012859Holding sleeveALTATEC GmbHJ5302.33002026-08-17
04099797012866Holding sleeveALTATEC GmbHJ5302.38002026-08-17
04099797012873Holding sleeveALTATEC GmbHJ5302.43002026-08-17
04099797012880Holding sleeveALTATEC GmbHJ5302.50002026-08-17
04099797012897Holding sleeveALTATEC GmbHJ5302.60002026-08-17
B382SD9144941010Surgical DirectSurgical Direct, Inc.SD9144941012026-08-14
00810135961288ToejackNVision Biomedical Technologies, Inc.TJB-1000T-PKS2026-07-29
00841132135280PediNailORTHOPEDIATRICS CORP.21-1500-0072017-02-15
00841132135297PediNailORTHOPEDIATRICS CORP.21-1500-0102017-02-15
00841132135303PediNailORTHOPEDIATRICS CORP.21-1500-0122017-02-15
10705034768977Click'XSynthes GmbH314.0682016-12-31
10705034768984Click'XSynthes GmbH314.0692016-12-31
07613327172775ASNISStryker GmbH7053692016-07-25
008401944960943P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3120-60002026-06-10
008401944963603P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3124-60002026-06-10
008401944966363P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3127-60002026-06-10
008401944969023P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3135-60002026-06-10
00889795154552Spider Monkey Bone Transport SystemParagon 28, Inc.P38-910-00012026-06-10
00889795154569Spider Monkey Bone Transport SystemParagon 28, Inc.P38-910-00022026-06-10
10855068008447Soft Tissue SleeveCURVAFIX, INC.CTS-0012022-06-20
10855068008454Drill SleeveCURVAFIX, INC.CDS-0012022-06-20
10855068008461Spiked Start Sleeve, CannulatedCURVAFIX, INC.CSS-0012022-06-20
10855068008478Steerable Guide SleeveCURVAFIX, INC.CGS-0022022-06-20
10855068008577Steerable Guide Sleeve, Small ImplantCURVAFIX, INC.GSS-0012022-12-05
00857915007699Locking AttachmentA.M. SURGICAL, INC.9600-042026-05-20
07290115932492Tower STPREMIA SPINE LTD886062026-06-01
07290115934076Tower ST Long WindowPREMIA SPINE LTD889742026-06-01
00190376475646InvictusALPHATEC SPINE, INC.17171-22023-01-05
00763000880200n/aMEDTRONIC SOFAMOR DANEK, INC.79670832025-10-17
00810097803831RESCUE SLEEVEOsteocentric Technologies, Inc.101-00382025-11-21
00840124516649FibFixFUSION ORTHOPEDICS, LLCTN-FN-80372026-04-09
00840124516656FibFixFUSION ORTHOPEDICS, LLCTN-FN-80472026-04-09
00840124516663FibFixFUSION ORTHOPEDICS, LLCTN-FN-80572026-04-09
00840124516670FibFixFUSION ORTHOPEDICS, LLCTN-FN-85372026-04-09
00840124516687FibFixFUSION ORTHOPEDICS, LLCTN-FN-85472026-04-09
00840124516694FibFixFUSION ORTHOPEDICS, LLCTN-FN-85572026-04-09
00840124516717FibFixFUSION ORTHOPEDICS, LLCTN-FN-70102026-04-09
00840124516724FibFixFUSION ORTHOPEDICS, LLCTN-FN-70202026-04-09
00840124516731FibFixFUSION ORTHOPEDICS, LLCTN-FN-70152026-04-09
00840124516748FibFixFUSION ORTHOPEDICS, LLCTN-FN-80162026-04-09
00840124516755FibFixFUSION ORTHOPEDICS, LLCTN-FN-70992026-04-09
00840124517653FibFixFUSION ORTHOPEDICS, LLCTN-FN-8037-S2026-04-09