FDA.reportPublic FDA data

CHS

Primary DI
03596010061928
Brand
CHS
Company
Smith & Nephew, Inc.
Model
121117
Catalog number
121117
Device description
COMPRESSION HIP SCREW HEX HEAD COMPRESSING SCREW 28.5MM
Published
2015-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210837000
K213126000
K954712000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210837000Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.2021-06-29HRS
K213126000Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screwsSmith & Nephew, Inc.2022-09-29JDO
K954712000INTRAMEDULLARY HIP SCREW (MODIFICATION)Smith & Nephew Richards, Inc.1995-10-31KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
23596010061922PackageGS16In Commercial Distribution
03596010061928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2359601006192223596010061922
03596010061928035960100619283596010061928

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00: -

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010194534SYNERGY71306709713067092015-08-30
03596010194541SYNERGY71306710713067102015-08-30
03596010194558SYNERGY71306711713067112015-08-30
03596010194565SYNERGY71306712713067122015-08-30
03596010194572SYNERGY71306713713067132015-08-30
03596010194589SYNERGY71306714713067142015-08-30
03596010194596SYNERGY71306715713067152015-08-30
03596010194602SYNERGY71306716713067162015-08-30
03596010194619SYNERGY71306717713067172015-08-30
03596010194626SYNERGY71306718713067182015-08-30
03596010384935SYNERGY71306409713064092015-08-29
03596010384942SYNERGY71306410713064102015-08-29
03596010384966SYNERGY71306411713064112015-08-29
03596010384973SYNERGY71306412713064122015-08-29
03596010384980SYNERGY71306413713064132015-08-30
03596010384997SYNERGY71306414713064142015-08-30
03596010385000SYNERGY71306415713064152015-08-30
03596010385017SYNERGY71306416713064162015-08-30
03596010385024SYNERGY71306417713064172015-08-30
03596010385031SYNERGY71306418713064182015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08032909626380ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-17
08051739535730ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-10
08059386747391DOLPHIXCITIEFFE SRLKTT2025-04-02
10080196692729MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692866MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692910MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692927MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692941MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10080196692965MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002065MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002072MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002089MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002096MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002102MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002119MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002126MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002133MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002140MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002157MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002164MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002171MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002188MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002195MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002201MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002218MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002225MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
10193489002232MEDLINEMEDLINE INDUSTRIES, INC.KTT2025-01-29
08032909624263ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11