FDA.reportPublic FDA data

Orthopaedic intraoperative positioning pin, reusable

Definition
A nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a reusable device.
GUDID devices
134
Last updated
2026-10-13 01:08:57

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810112592856TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSWire Tack for 3.0/3.5/4.0 Plates2024-02-23
00810112596137TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSWire Tack for 2.0/2.5/3.0 Plates2024-02-23
00810112596144TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSCompression Wire 1.6mm for 3.0/3.5/4.0 Plates, Thr2024-02-23
00810112596151TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSCompression Wire 1.6mm for 3.0/3.5/4.0 Plates, Thr2024-02-23
00810112596168TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSCompression Wire 1.6mm for 3.0/3.5/4.0 Plates, Thr2024-02-23
00810112596175TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSCompression Wire 1.6mm for 3.0/3.5/4.0 Plates, Thr2024-02-23
00810112596182TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSCompression Wire 1.6mm for 3.0/3.5/4.0 Plates, Thr2024-02-23
00810112596199TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSCompression Wire 1.6mm for 2.0/2.5/3.0 Plates, Thr2024-02-23
00810112596205TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSCompression Wire 1.6mm for 2.0/2.5/3.0 Plates, Thr2024-02-23
00810112596212TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSCompression Wire 1.6mm for 2.0/2.5/3.0 Plates, Thr2024-02-23
00810112596229TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSCompression Wire 1.6mm for 2.0/2.5/3.0 Plates, Thr2024-02-23
00810112596236TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSCompression Wire 1.6mm for 2.0/2.5/3.0 Plates, Thr2024-02-23
00810112597509TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMS03.900.3642026-02-10
03700879515687Airlock®NOVASTEPXPP010062026-08-25
10885862019882ExactechExactech, Inc.120-65-402015-08-10
10885862019899ExactechExactech, Inc.120-65-452015-08-10
10885862019905ExactechExactech, Inc.120-65-502015-08-10
10885862019912ExactechExactech, Inc.120-65-552015-08-10
10885862019929ExactechExactech, Inc.120-65-602015-08-10
10885862019936ExactechExactech, Inc.120-65-702015-08-10
10885862132260ExactechExactech, Inc.SC45-252015-10-30
10885862132277ExactechExactech, Inc.SC45-302015-10-30
10885862132284ExactechExactech, Inc.SC45-352015-10-30
10885862132291ExactechExactech, Inc.SC45-402015-10-30
10885862132307ExactechExactech, Inc.SC45-452015-10-30
10885862132314ExactechExactech, Inc.SC45-502015-10-30
10885862132321ExactechExactech, Inc.SC45-552015-10-30
10885862132338ExactechExactech, Inc.SC45-602015-10-30
10885862132345ExactechExactech, Inc.SC45-652015-10-30
10885862132352ExactechExactech, Inc.SC45-702015-10-30
10885862085955EquinoxeExactech, Inc.315-98-312022-07-28
10885862253620GPSExactech, Inc.521-78-032022-09-19
10885862541987VantageExactech, Inc.351-90-262022-07-28
08057717553734BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLGuide wire Ø 2 mm - Bioplan2026-08-18
00840286860390Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.3000-0-00622026-07-09
08800089483440Surgical InstrumentJeil Medical CorporationS111-356-42026-06-10
08800089483464Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationSO-S111-356-42026-06-10
03596010181749TC-100Smith & Nephew, Inc.711703152015-09-28
00810211044126Ultra Compression Screw SystemPace Surgical, Inc.PS2-24000202026-04-27
00810211044133Ultra Compression Screw SystemPace Surgical, Inc.PS2-24000342026-04-27
00810211044140Ultra Compression Screw SystemPace Surgical, Inc.PS2-24000442026-04-27
00850080482032Bone PinUnique SurgicalMedacta, Fluted2025-12-18
03662663108782Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLC07.00656.0022026-01-12
03662663194457SC-AcuFix Anterior Cervical Plate SystemHighridge Medical, LLC457-12026-03-31
08800089479375Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationSO-111-356-42025-12-04
M719GSI255010SIros-O Sacroiliac Joint Fusion System Genesys Orthopedics Systems LLC12025-10-15
M719GSI255020SIros-O Sacroiliac Joint Fusion System Genesys Orthopedics Systems LLC12025-10-15
M719GSI255030SIros-O Sacroiliac Joint Fusion System Genesys Orthopedics Systems LLC12025-10-15
M719GSI256NSR0SIros-O Sacroiliac Joint Fusion System Genesys Orthopedics Systems LLC12025-10-15
M719GSI256NSS0SIros-O Sacroiliac Joint Fusion System Genesys Orthopedics Systems LLC12025-10-16
M719GSI256SBR0SIros-O Sacroiliac Joint Fusion System Genesys Orthopedics Systems LLC12025-10-15
M719GSI256SBS0SIros-O Sacroiliac Joint Fusion System Genesys Orthopedics Systems LLC12025-10-16
M719GSI256SSR0SIros-O Sacroiliac Joint Fusion System Genesys Orthopedics Systems LLC12025-10-16
M719GSI256SSS0SIros-O Sacroiliac Joint Fusion System Genesys Orthopedics Systems LLC12025-10-16
M719GSI3140SIros-O Sacroiliac Joint Fusion System Genesys Orthopedics Systems LLC12025-10-16
03662663141239MaxAn Anterior Cervical Plate SystemHighridge Medical, LLC14-5210722026-02-16
03662663141246MaxAn Anterior Cervical Plate SystemHighridge Medical, LLC14-5210742026-02-13
03662663141253MaxAn Anterior Cervical Plate SystemHighridge Medical, LLC14-5210762026-02-13
03662663108713Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLC07.00394.0022026-02-11
M719GSIX3000SIros-XGenesys Orthopedics Systems LLC12026-01-30
M719GSIX3010SIros-XGenesys Orthopedics Systems LLC12026-01-30
00841731134769Hintermann Series VILEX LLCHT-399002026-01-16
03662663243582Alta ACDF SystemHighridge Medical, LLC8440-20102025-12-18
03662663243599Alta ACDF SystemHighridge Medical, LLC8440-20112025-12-18
03662663243605Alta ACDF SystemHighridge Medical, LLC8440-20122025-12-18
03662663243612Alta ACDF SystemHighridge Medical, LLC8440-20132025-12-18
03662663243629Alta ACDF SystemHighridge Medical, LLC8440-20142025-12-18
03662663243636Alta ACDF SystemHighridge Medical, LLC8440-20152025-12-18
03662663243643Alta ACDF SystemHighridge Medical, LLC8440-20162025-12-18
03662663243650Alta ACDF SystemHighridge Medical, LLC8440-20172025-12-18
03662663243667Alta ACDF SystemHighridge Medical, LLC8440-20182025-12-18
08800089479405Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationSO-111-356-42025-12-04
08056693028007INTRAUMA SURGICAL INSTRUMENTINTRAUMA SPAS2352025-11-27
00841731134752Hintermann Series VILEX LLCHT-397312025-09-17
00841731134776Hintermann Series VILEX LLCHT-398952025-09-17
00841731134783Hintermann Series VILEX LLCHT-398702025-09-17
00841731134790Hintermann Series VILEX LLCHT-397702025-09-17
00841731134806Hintermann Series VILEX LLCHT-398552025-09-17
00841731142351Hintermann Series VILEX LLCHT-396042025-09-17
00841731142368Hintermann Series VILEX LLCHT-396052025-09-17