FDA.reportPublic FDA data

" 11"" Guide Wire"

Primary DI
00850040139570
Brand
" 11"" Guide Wire"
Company
Surgentec, LLC
Model
SR11-5001
Published
2026-03-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211855000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211855000Ion Facet Screw SystemSurGenTec, LLC2022-02-25MRW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850040139570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040139570008500401395708500401395700850040139570

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, single-useA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
004095409
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810131880736OsteoFlo Synthetic HydroPutty HFP - 1ccOHFP-S-012025-06-10
00810131880743OsteoFlo Synthetic HydroPutty HFP - 3ccOHFP-S-032025-06-10
00810131880750OsteoFlo Synthetic HydroPutty HFP - 6ccOHFP-S-062025-06-10
00810131880767OsteoFlo Synthetic HydroPutty HFP - 12ccOHFP-S-122025-06-10
00810131881139OsteoFlo Synthetic Nanoputty Syringe - 5cc - IOSALONP-S-05 - IB2025-06-10
00810131881146OsteoFlo Synthetic Nanoputty Syringe - 10cc - IOSALONP-S-10 - IB2025-06-10
00810131881153OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSALONP-T-1000-IB2025-06-10
00810131881160OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSALONP-T-1000-IB2025-06-10
00810131881177OsteoFlo HydroPutty Synthetic HFP - 6cc Labeled - IOSALOHFP-S-06-IB2025-06-10
00810131881184OsteoFlo HydroPutty Synthetic HFP - 12cc Labeled - IOSALOHFP-S-12-IB2025-06-10
00858406007648OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 5ccONP-K-5002025-06-10
00858406007655OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 10ccONP-K-10002025-06-10
00858406007662OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 1ccONP-U-012025-06-10
00858406007679OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 2.5ccONP-U-022025-06-10
00858406007686OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 5ccONP-U-052025-06-10
00858406007693OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 10ccONP-U-102025-06-10
00810131880545Global Tip Adapter - LongGG-NTA-122025-03-14
00810131881191Global Tip Adapter - NarrowGG-NTA-142025-03-14
00810131881207Bullet Global Tip AdapterGG-NTA-132025-03-14
00858406007150Bullet Tip AdapterGG-NTA-032025-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606197472OMEGA XPSPINAL ELEMENTS, INC.LXH2026-10-29
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00842078100479IO FiXEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078100486XMCPEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078112410Axis BeamsEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078116197AlignXEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078123584KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124178Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124185Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124215Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129609KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129616KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129623KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129753IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129777IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129784IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129791IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
04250337122432iLESSYS® Interlaminar Endoscopic Surgical SystemJoimax GmbHLXH2026-10-29
07630699700689Knee InstrumentsMedacta International SALXH2026-10-29
08800017276182LOSPACorentec Co., LtdLXH2026-10-29
08806373878039LOSPACorentec Co., LtdLXH2026-10-29
08806373889653LOSPACorentec Co., LtdLXH2026-10-29
08806373894190LOSPACorentec Co., LtdLXH2026-10-29
10850070500101Core Wire, Removal Tool, ReusableCURVAFIX, INC.LXH2026-10-29
10855068008935Removal Tool Core Wire, DisposableCURVAFIX, INC.LXH2026-10-29
10888857615779K2M General InstrumentsVB Spine LLCLXH2026-10-28
M739193990906Non-Modular Convex TrialCAPTIVA SPINE, INC.LXH2026-10-28
M739193996906Non-Modular Lordotic Trial AssemblyCAPTIVA SPINE, INC.LXH2026-10-28
M739243999005SG Implant Driver-SCAPTIVA SPINE, INC.LXH2026-10-28
M739985202229Marking PinCAPTIVA SPINE, INC.LXH2026-10-28