FDA.reportPublic FDA data

Cannulated Screws

Primary DI
03596010298126
Brand
Cannulated Screws
Company
Smith & Nephew, Inc.
Model
71110400
Catalog number
71110400
Device description
1.9MM X 300 TIP THREADED GUIDE PIN
Published
2015-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPLATE, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123055000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123055000SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.2013-01-25HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
23596010298120PackageGS16In Commercial Distribution
03596010298126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2359601029812023596010298120
03596010298126035960102981263596010298126

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic intraoperative positioning pin, single-useA 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 single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556832448Salto Talaris Total Ankle ProsthesisMJU048TMJU048T2023-02-02
00885556165560NA76515310765153102026-07-16
00885556923023NA76547001765470012026-07-16
00885556925089NA74034445740344452026-07-14
00885556925379CORIOGRAPHROB20032ROB200322026-07-08
00885556925386CORIOGRAPHROB20031ROB200312026-07-08
00885556904879EVOS70887105708871052026-06-25
00885556904923EVOS70897130708971302026-06-25
00885556906163EVOS70879090708790902026-06-25
00885556906170EVOS70879095708790952026-06-25
00885556906187EVOS70879100708791002026-06-25
00885556906194EVOS70879105708791052026-06-25
00885556906200EVOS70879110708791102026-06-25
00885556906217EVOS70879115708791152026-06-25
00885556906224EVOS70879120708791202026-06-25
00885556906231EVOS70879125708791252026-06-25
00885556906248EVOS70879130708791302026-06-25
00885556906255EVOS70879135708791352026-06-25
00885556906262EVOS70879140708791402026-06-25
00885556906279EVOS70879145708791452026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00888233028882Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233028899Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086110Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086127Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086134Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086141Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086158Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086165Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086172Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086189Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086196Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086202Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086219Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
07613327649109T2, PANGEAStryker GmbHHRS2025-09-25
07613327649130T2, PANGEAStryker GmbHHRS2025-09-25
07613327649253T2, PANGEAStryker GmbHHRS2025-09-25
07613327649260T2, PANGEAStryker GmbHHRS2025-09-25
07613327649277T2, PANGEAStryker GmbHHRS2025-09-25
07613327649284T2, PANGEAStryker GmbHHRS2025-09-25
07613327649291T2, PANGEAStryker GmbHHRS2025-09-25
07613327649307T2, PANGEAStryker GmbHHRS2025-09-25
07613327649314T2, PANGEAStryker GmbHHRS2025-09-25
07613327649321T2, PANGEAStryker GmbHHRS2025-09-25
07613327649338T2, PANGEAStryker GmbHHRS2025-09-25
07613327649345T2, PANGEAStryker GmbHHRS2025-09-25
07613327649352T2, PANGEAStryker GmbHHRS2025-09-25
07613327649369T2, PANGEAStryker GmbHHRS2025-09-25
07613327649376T2, PANGEAStryker GmbHHRS2025-09-25
07613327649383T2, PANGEAStryker GmbHHRS2025-09-25