FDA.reportPublic FDA data

IMHS

Primary DI
03596010519238
Brand
IMHS
Company
Smith & Nephew, Inc.
Model
71687015
Catalog number
71687015
Device description
IMHS CP 16MM SHORT TRIAL RIGHT
Published
2015-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122170000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122170000SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.2012-10-19HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010519238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010519238035960105192383596010519238

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail trialA cylindrical rod that simulates an orthopaedic bone nail designed to be placed into the proximal end of the intramedullary canal of a long bone (e.g., through the femoral head) to act as a decisive reference point for the subsequent drilling and insertion of guide wires/bone screws to secure the fracture(s); the dummy nail is then exchanged with the implant nail. An orthopaedic implant/trial implant holder is connected to the exposed end of the dummy nail whilst in situ and it is this alignment together with a connecting screw and an aiming arm which provides the surgeon with the correct calculated positions and angles for the final placement of the bone screws. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15
00885556830543PyroCarbon Modular Radial HeadTRL-310-01TRL-310-012026-09-24
00885556830550PyroCarbon Modular Radial HeadTRL-310-02TRL-310-022026-09-24
00885556830567PyroCarbon Modular Radial HeadTRL-310-03TRL-310-032026-09-24
00885556830574PyroCarbon Modular Radial HeadTRL-310-04TRL-310-042026-09-24
00885556839690Total Foot System 2CSA-800-06CSA-800-062026-09-24
00885556839706Total Foot System 2CSA-800-07CSA-800-072026-09-24
00885556854778Cadence Total Ankle SystemCSA-1020-0014CSA-1020-00142026-09-24
00885556859636Titan Modular Shoulder SystemCSA092009CSA0920092026-09-24
00885556859643Titan Modular Shoulder SystemCSA092010CSA0920102026-09-24
00885556859650Titan Modular Shoulder SystemCSA092011CSA0920112026-09-24
00885556859698Titan Modular Shoulder SystemCSA-0920-15CSA-0920-152026-09-24
00885556859704Titan Modular Shoulder SystemCSA-0920-16CSA-0920-162026-09-24
00885556859711Titan Modular Shoulder SystemCSA-0920-17CSA-0920-172026-09-24
00885556859728Titan Modular Shoulder SystemCSA-0920-18CSA-0920-182026-09-24
00885556859735Titan Modular Shoulder SystemCSA-0920-19CSA-0920-192026-09-24
00885556859742Titan Modular Shoulder SystemCSA-0920-20CSA-0920-202026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982471415AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471439AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
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00193982471491AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471514AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471538AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471767AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471781AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471804AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471828AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471842AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471866AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471880AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472115AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472139AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472153AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472177AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472191AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472214AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472238AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473822AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473846AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473860AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473884AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473907AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473921AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473945AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982474171AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982474195AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14