FDA.reportPublic FDA data

REDAPT

Primary DI
00885556580455
Brand
REDAPT
Company
Smith & Nephew, Inc.
Model
71354862
Catalog number
71354862
Device description
REDAPT 300MM SLEEVED REVISION STEM SIZE 19 HIGH OFFSET
Published
2017-05-11
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
00885556580455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556580455008855565804558855565804550885556580455

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
00885556833049Salto Talaris Total Ankle ProsthesisMJU547TMJU547T2022-12-22
00885556833339Salto Talaris Total Ankle ProsthesisMJU606TMJU606T2022-12-22
00885556855560Freedom Wrist Arthroplasty System3482153482152022-12-22
00885556865859Subtalar MBA Implant0500160500162023-01-19
00885556917435Real IntelligenceROB20040ROB200402024-04-10
00885556780886REAL INTELLIGENCEROB10013SROB10013S2022-01-13
00885556757321REAL INTELLIGENCEROB10013ROB100132020-07-02
03596010411020VERSABOND71271140712711402015-08-29
03596010494726VERSABOND71271340712713402015-08-29
03596010507372VERSABOND71271440712714402015-09-28
03596010033246NA1100281100282015-08-25
03596010038852NA1114301114302015-08-25
03596010038890NA1114341114342015-08-25
03596010041968BUCK1124281124282015-08-25
03596010384591MIXOR71270041712700412015-08-29
03596010384607MIXOR71270042712700422015-08-29
03596010384638MIXOR71270051712700512015-08-29
03596010384645MIXOR71270052712700522015-08-29
03596010437617RENOVATION71369045713690452015-08-30
03596010472175MIXOR71270060712700602015-08-29

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