FDA.reportPublic FDA data

Intraoperative orthopaedic bone pin/screw, single-use

Definition
A small rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) and/or implantable device (e.g., fixation plate) to the bone during an orthopaedic surgical procedure; it is not left in situ after the procedure. It may be wholly- or partially-threaded for screwing into bone, and may have other physical features to enable fixation of surgical instruments/devices. It is made of metallic (e.g., stainless steel) or polymer (radiolucent) material and is available in various shapes and sizes. This is a single-use device.
GUDID devices
189
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
14053613164433KOMET GUIDE PIN/SCREWGebr. Brasseler GmbH & Co. KGGP002.089.032.M42018-07-10
14053613281451KOMET GUIDE PIN/SCREWGebr. Brasseler GmbH & Co. KGGS910.140.40.M52020-12-18
B167S1700455000CURE LPMEDITECH SPINE, LLCS1-700-455-002017-10-11
M7399851482290TransFastenCAPTIVA SPINE, INC.98514-82292023-08-16
10885403004162V. MuellerSTERIS CORPORATIONS-00982018-09-14
10885403004179V. MuellerSTERIS CORPORATIONS-00972018-09-14
10885403004186V. MuellerSTERIS CORPORATIONS-00962018-09-14
10885403004193V. MuellerSTERIS CORPORATIONS-00922018-09-14
00818614022635ABS Med Distraction PinMEDLINE INDUSTRIES, INC.MDS90912122023-08-29
10818614022649ABS Med Distraction PinMaruho Medical, Inc.MDS90914142023-08-29
24053613287221Guide Pin & Guide Screw SetGebr. Brasseler GmbH & Co. KGGS06D.067.0322023-08-17
M7399851402290TransFastenCAPTIVA SPINE, INC.98514-02292023-08-16
M7399851412290TransFastenCAPTIVA SPINE, INC.98514-12292023-08-16
M7399851422290TransFastenCAPTIVA SPINE, INC.98514-22292023-08-16
M7399851432290TransFastenCAPTIVA SPINE, INC.98514-32292023-08-16
M7399851442290TransFastenCAPTIVA SPINE, INC.98514-42292023-08-16
M7399851443050TransFastenCAPTIVA SPINE, INC.98514-43052023-08-16
M7399851452290TransFastenCAPTIVA SPINE, INC.98514-52292023-08-16
M7399851462290TransFastenCAPTIVA SPINE, INC.98514-62292023-08-16
M7399851472290TransFastenCAPTIVA SPINE, INC.98514-72292023-08-16
24053613285920Guide ScrewGebr. Brasseler GmbH & Co. KGPC32272023-07-24
24053613285937Guide PinGebr. Brasseler GmbH & Co. KGPC32752023-07-24
24053613285944Guide PinGebr. Brasseler GmbH & Co. KGPC3275-42023-07-24
24053613285951Guide ScrewGebr. Brasseler GmbH & Co. KGPC35482023-07-24
24053613285968Guide PinGebr. Brasseler GmbH & Co. KGPC3290-42023-07-24
03596010175175CHSSmith & Nephew, Inc.711232002015-08-25
03596010175472CHSSmith & Nephew, Inc.711232682015-08-25
B90823991238Isto Disposable Funnel System Shooter 6mm Cannula, Pusher 5.5mmMainstream Medical Devices, LLC239-91-2382023-07-20
00840180515013General InstrumentsALPHATEC SPINE, INC.CI-11215-302023-07-16
00190376044170BattalionALPHATEC SPINE, INC.27435-S2020-06-17
00840180517895General InstrumentsALPHATEC SPINE, INC.CI-11311-082023-07-08
10818614021406Distraction ScrewMaruho Medical, Inc.909-122023-01-26
10818614021413Distraction ScrewMaruho Medical, Inc.909-142023-01-26
10818614022601Distraction Pin, 12MM pouchMaruho Medical, Inc.SS-0088S2022-12-19
10818614022618Distraction Pin, 14MM pouchMaruho Medical, Inc.SS-0089S 2022-12-19
00885556871386AETOS Shoulder SystemSmith & Nephew, Inc.GDW-0990-839NT2023-02-13
00887919160823Brasseler USAPeter Brasseler Holdings, LLC000022S02023-01-25
00887919160830Brasseler USAPeter Brasseler Holdings, LLC000022S12023-01-25
00887919160885Brasseler USAPeter Brasseler Holdings, LLC000024S02023-01-25
00887919160892Brasseler USAPeter Brasseler Holdings, LLC000024S12023-01-25
00887919161035Brasseler USAPeter Brasseler Holdings, LLC000063S02023-01-25
00887919161042Brasseler USAPeter Brasseler Holdings, LLC000063S12023-01-25
00887919161103Brasseler USAPeter Brasseler Holdings, LLC000065S02023-01-25
00887919161110Brasseler USAPeter Brasseler Holdings, LLC000065S12023-01-25
00887919164739Brasseler USAPeter Brasseler Holdings, LLC000112S02023-01-25
00887919164746Brasseler USAPeter Brasseler Holdings, LLC000112S12023-01-25
00887919164791Brasseler USAPeter Brasseler Holdings, LLC000113U02023-01-25
00887919164845Brasseler USAPeter Brasseler Holdings, LLC000114S02023-01-25
00887919164852Brasseler USAPeter Brasseler Holdings, LLC000114S12023-01-25
00887919172185Brasseler USAPeter Brasseler Holdings, LLC000416S02023-01-25
00887919172192Brasseler USAPeter Brasseler Holdings, LLC000416S12023-01-25
00887919172260Brasseler USAPeter Brasseler Holdings, LLC000422S02023-01-25
00887919172277Brasseler USAPeter Brasseler Holdings, LLC000422S12023-01-25
00887919172352Brasseler USAPeter Brasseler Holdings, LLC000437S02023-01-25
00887919172369Brasseler USAPeter Brasseler Holdings, LLC000437S12023-01-25
00887919172444Brasseler USAPeter Brasseler Holdings, LLC000438S02023-01-25
00887919172451Brasseler USAPeter Brasseler Holdings, LLC000438S12023-01-25
00887919172536Brasseler USAPeter Brasseler Holdings, LLC000439S02023-01-25
00887919172543Brasseler USAPeter Brasseler Holdings, LLC000439S12023-01-25
00887919173939Brasseler USAPeter Brasseler Holdings, LLC000464S02023-01-25
00887919173946Brasseler USAPeter Brasseler Holdings, LLC000464S12023-01-25
00887919174011Brasseler USAPeter Brasseler Holdings, LLC000465S02023-01-25
00887919174028Brasseler USAPeter Brasseler Holdings, LLC000465S12023-01-25
00887919174110Brasseler USAPeter Brasseler Holdings, LLC000466S02023-01-25
00887919174127Brasseler USAPeter Brasseler Holdings, LLC000466S12023-01-25
00887919179702Brasseler USAPeter Brasseler Holdings, LLC000847S02023-01-25
00887919179719Brasseler USAPeter Brasseler Holdings, LLC000847S12023-01-25
00887919179757Brasseler USAPeter Brasseler Holdings, LLC000848S02023-01-25
00887919179764Brasseler USAPeter Brasseler Holdings, LLC000848S12023-01-25
00887919179801Brasseler USAPeter Brasseler Holdings, LLC000849S02023-01-25
00887919179818Brasseler USAPeter Brasseler Holdings, LLC000849S12023-01-25
00887919179856Brasseler USAPeter Brasseler Holdings, LLC000850S02023-01-25
00887919179863Brasseler USAPeter Brasseler Holdings, LLC000850S12023-01-25
00887919179900Brasseler USAPeter Brasseler Holdings, LLC000851S02023-01-25
00887919179917Brasseler USAPeter Brasseler Holdings, LLC000851S12023-01-25
00887919179955Brasseler USAPeter Brasseler Holdings, LLC000862S02023-01-25
00887919179962Brasseler USAPeter Brasseler Holdings, LLC000862S12023-01-25
00887919180616Brasseler USAPeter Brasseler Holdings, LLC000883S02023-01-25
00887919180623Brasseler USAPeter Brasseler Holdings, LLC000883S12023-01-25
00887919180661Brasseler USAPeter Brasseler Holdings, LLC000884S02023-01-25