NA

Primary DI
03596010061140
Brand
NA
Company
Smith & Nephew, Inc.
Model
120709
Catalog number
120709
Device description
ACETABULAR CEMENT RESTRICTOR POLYETHYLENE LARGE 38.10MM
Published
2015-08-25
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
LZNCEMENT OBTURATOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZNCement ObturatorGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K791125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K791125000PLUG-LOK CEMENT RESTIRCTORRichard'S Medical Equip., Inc.1979-06-27LZN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010061140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010061140035960100611403596010061140

GMDN Terms#

Term, Definition table
TermDefinition
Polymer orthopaedic cement restrictor, non-bioabsorbable, sterileA sterile, non-bioabsorbable, implantable device designed to be inserted into the medullary canal of a bone (e.g., femur, tibia, or humerus) during orthopaedic surgery to prevent cement progression in the diaphysis and therefore facilitate cement pressurization during the introduction of an implant. It is typically made of polyetheretherketone (PEEK) or ultrahigh molecular weight polyethylene (UHMWPE) and is available in a variety of designs, e.g., straight or tapered, hollow with a fenestrated surface, and it may have a toothed surface to prevent its migration from the desired location. It may incorporate a metal orientation marker for radiographs and is not intended for spinal indication.

Sterilization Methods#

Method table
Method

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
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
00885556906286EVOS70879150708791502026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760177046542CLEARCUTTEKNIMEDLZN2020-11-25
03760177046573CLEARCUTTEKNIMEDLZN2020-11-25
03760177046603CLEARCUTTEKNIMEDLZN2020-11-25
03760177046634CLEARCUTTEKNIMEDLZN2020-11-25
03760177046665CLEARCUTTEKNIMEDLZN2020-11-25
03760177046696CLEARCUTTEKNIMEDLZN2020-11-25
03760177046535CLEARCUTTEKNIMEDLZN2020-09-24
00889024510326NAZimmer, Inc.LZN2018-09-14
00889024510333NAZimmer, Inc.LZN2018-09-14
00889024510340NAZimmer, Inc.LZN2018-09-14
00889024510357NAZimmer, Inc.LZN2018-09-14
00889024510364NAZimmer, Inc.LZN2018-09-14
00889024510371NAZimmer, Inc.LZN2018-09-14
00888912023443DJO SURGICALEncore Medical, L.P.LZN2017-05-04
00888912023450DJO SURGICALEncore Medical, L.P.LZN2017-05-04
00888912023467DJO SURGICALEncore Medical, L.P.LZN2017-05-04
00888912023474DJO SURGICALEncore Medical, L.P.LZN2017-05-04
00888912023481DJO SURGICALEncore Medical, L.P.LZN2017-05-04
00888912073806DJO SURGICALEncore Medical, L.P.LZN2017-05-04
00889024376724NAZimmer, Inc.LZN2016-08-31
00889024376748NAZimmer, Inc.LZN2016-08-31
00889024376755NAZimmer, Inc.LZN2016-08-31
00889024380189NAZimmer, Inc.LZN2016-08-31
00889024432918NAZimmer, Inc.LZN2016-07-15
00889024432970NAZimmer, Inc.LZN2016-05-24
00889024432987NAZimmer, Inc.LZN2016-05-24
00889024432994NAZimmer, Inc.LZN2016-05-24
00889024433007NAZimmer, Inc.LZN2016-05-24
00889024433014NAZimmer, Inc.LZN2016-05-24
00889024433021NAZimmer, Inc.LZN2016-05-24