FDA.reportPublic FDA data

REDAPT

Primary DI
00885556580158
Brand
REDAPT
Company
Smith & Nephew, Inc.
Model
71354828
Catalog number
71354828
Device description
REDAPT 240MM SLEEVED REVISION STEM SIZE 21 HIGH OFFSET
Published
2017-05-08
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
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162303000
K211176000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162303000REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.2017-05-01MEH
K211176000Smith & Nephew Hip SystemsSmith & Nephew, Inc.2022-07-01LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556580158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556580158008855565801588855565801580885556580158

Storage And Handling#

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

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
00885556925171REAL INTELLIGENCEROB100021FROB100021F2026-07-30
00885556925188REAL INTELLIGENCEROB100022FROB100022F2026-07-30
00885556925195REAL INTELLIGENCEROB10024FROB10024F2026-07-30
00885556925201REAL INTELLIGENCEROB10025FROB10025F2026-07-30
00885556925218REAL INTELLIGENCEROB10027FROB10027F2026-07-30
00885556925225REAL INTELLIGENCEROB10003FROB10003F2026-07-30
00885556925232REAL INTELLIGENCEROB10013FROB10013F2026-07-30
00885556925249REAL INTELLIGENCEROB10015FROB10015F2026-07-30
00885556757277REAL INTELLIGENCEROB10010ROB100102020-07-02
00885556757307REAL INTELLIGENCEROB10011ROB100112020-07-02
00885556757314REAL INTELLIGENCEROB10012ROB100122020-07-02
00885556909393NA52856B52856B2025-09-24
00885556909317NA52858-0152858-012025-05-08
00885556909331NA52858-0252858-022025-05-08
00885556909348NA55085550852025-05-08
00885556909362NA52781-1052781-102025-05-08
00885556909386NA52876B52876B2025-05-08
00885556909423NA52855-4052855-402025-05-08
00885556909430NA52855-6552855-652025-05-08
00885556909447NA52781A52781A2025-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024713512G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713529G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713536G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713543G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713550G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713567G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713574G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713581G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713598G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713604G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713611G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713628G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713635G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713642G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713659G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713666G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713673G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713680G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713697G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713703G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713734G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713741G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713758G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713765G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713772G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713789G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713796G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713802G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713819G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713826G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03