FDA.reportPublic FDA data

PROMOS

Primary DI
07611996127218
Brand
PROMOS
Company
Smith & Nephew, Inc.
Model
75101982
Catalog number
75101982
Device description
HOLDING FORK
Published
2015-11-25
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
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113012000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113012000PROMOS MODULAR SHOULDER SYSTEMSmith & Nephew, Inc.2012-01-05KWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611996127218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611996127218076119961272187611996127218

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA 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. It may be used for the following applications: 1) to hold/align/fix bone preparation 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 between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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
03596010627308JOURNEY71422341714223412015-08-30
03596010627315JOURNEY71422342714223422015-08-30
03596010627339JOURNEY71422344714223442015-08-30
03596010627346JOURNEY71422345714223452015-08-30
03596010627360JOURNEY71422347714223472015-08-30
03596010627377JOURNEY71422351714223512015-08-30
03596010627384JOURNEY71422352714223522015-08-30
03596010627391JOURNEY71422353714223532015-08-30
03596010627407JOURNEY71422354714223542015-08-30
03596010627421JOURNEY71422356714223562015-08-30
03596010627438JOURNEY71422357714223572015-08-30
03596010629777JOURNEY71422346714223462015-08-30
03596010627322JOURNEY71422343714223432015-08-30
03596010627414JOURNEY71422355714223552015-08-30
03596010627445JOURNEY71422361714223612015-08-30
03596010627452JOURNEY71422362714223622015-08-30
03596010627469JOURNEY71422363714223632015-08-30
03596010627476JOURNEY71422364714223642015-08-30
03596010627483JOURNEY71422365714223652015-08-30
03596010627490JOURNEY71422366714223662015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.KWS2026-05-28
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07613327355024REUNIONStryker GmbHKWS2022-11-15
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07613327355246REUNIONStryker GmbHKWS2022-11-15
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07613327355345REUNIONStryker GmbHKWS2022-11-15
07613327355369REUNIONStryker GmbHKWS2022-11-15
07613327355437REUNIONStryker GmbHKWS2022-11-15
07613327355444REUNIONStryker GmbHKWS2022-11-15
07613327355475REUNIONStryker GmbHKWS2022-11-15
07613327354409REUNIONStryker GmbHKWS2021-04-27
07613327354812REUNIONStryker GmbHKWS2021-04-27
07613327354836REUNIONStryker GmbHKWS2021-04-27
07613327354881REUNIONStryker GmbHKWS2021-04-27
07613327354973REUNIONStryker GmbHKWS2021-04-27
07613327354997REUNIONStryker GmbHKWS2021-04-27
07613327355031REUNIONStryker GmbHKWS2021-04-27
07613327355086REUNIONStryker GmbHKWS2021-04-27
07613327355130REUNIONStryker GmbHKWS2021-04-27
07613327355178REUNIONStryker GmbHKWS2021-04-27