FDA.reportPublic FDA data

BIRMINGHAM HIPTM RESURFACING

Primary DI
03596010503510
Brand
BIRMINGHAM HIPTM RESURFACING
Company
Smith & Nephew, Inc.
Model
901346
Catalog number
901346
Device description
BHR HEAD CENTRE CHECK JIG SZ 46
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
NXTProsthesis, hip, semi-constrained, metal/metal, resurfacing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXTProsthesis, Hip, Semi-Constrained, Metal/Metal, ResurfacingUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P040033000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040033000BIRMINGHAM HIP RESURFACING (BHR) SYSTEMSmith & Nephew, Inc.2006-05-09NXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010503510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010503510035960105035103596010503510

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning 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 [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) 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
03596010479235ECHELON71342011713420112015-09-28
03596010479266ECHELON71342014713420142015-09-28
03596010479273ECHELON71342015713420152015-09-28
03596010479297ECHELON71342017713420172015-09-28
03596010479303ECHELON71342018713420182015-09-28
03596010479310ECHELON71342019713420192015-09-28
03596010479341ECHELON71343012713430122015-09-28
03596010459749SYNERGY71309109713091092015-08-30
03596010459756SYNERGY71309110713091102015-08-30
03596010459787SYNERGY71309113713091132015-08-30
03596010459794SYNERGY71309114713091142015-08-30
03596010459817SYNERGY71309116713091162015-08-30
03596010459831SYNERGY71309118713091182015-08-30
03596010479259ECHELON71342013713420132015-09-28
03596010479280ECHELON71342016713420162015-09-28
03596010479358ECHELON71343013713430132015-09-28
03596010479365ECHELON71343014713430142015-09-28
03596010479389ECHELON71343016713430162015-09-28
03596010479396ECHELON71343017713430172015-09-28
03596010479402ECHELON71343018713430182015-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03596010533722BIRMINGHAM HIPSmith & Nephew, Inc.NXT2017-11-16
03596010504630BIRMINGHAM HIPSmith & Nephew, Inc.NXT2017-11-15
03596010504609BIRMINGHAMHIPRESURFACING(BHR)Smith & Nephew, Inc.NXT2017-11-13
03596010504616BIRMINGHAM HIPSmith & Nephew, Inc.NXT2017-11-13
03596010503428BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-11-25
03596010503435BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-11-25
03596010503442BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-11-25
03596010503459BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-11-25
03596010503480BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-11-25
03596010503497BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-11-25
03596010503503BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-11-25
03596010503527BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-11-25
03596010503541BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-11-25
03596010012302MATRIXSmith & Nephew, Inc.NXT2015-10-05
03596010581716NASmith & Nephew, Inc.NXT2015-09-28
03596010591555NASmith & Nephew, Inc.NXT2015-09-28
03596010533746BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-09-28
03596010533753BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-09-28
03596010533760BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-09-28
03596010533777BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-09-28
03596010577825BIRMINGHAM HIP RESURFACING (BHR)Smith & Nephew, Inc.NXT2015-05-07
03596010533647BIRMINGHAM HIP RESURFACING (BHR)Smith & Nephew, Inc.NXT2015-05-07
03596010533678BIRMINGHAM HIP RESURFACING (BHR)Smith & Nephew, Inc.NXT2015-05-07
03596010502551BIRMINGHAM HIP RESURFACING (BHR)Smith & Nephew, Inc.NXT2015-05-06
03596010502612BIRMINGHAM HIP RESURFACING (BHR)Smith & Nephew, Inc.NXT2015-05-06
03596010502629BIRMINGHAM HIP RESURFACING (BHR)Smith & Nephew, Inc.NXT2015-05-06
03596010502643BIRMINGHAM HIP RESURFACING (BHR)Smith & Nephew, Inc.NXT2015-05-06
03596010502674BIRMINGHAM HIP RESURFACING (BHR)Smith & Nephew, Inc.NXT2015-05-06
03596010533265BIRMINGHAM HIP RESURFACING (BHR)Smith & Nephew, Inc.NXT2015-05-06
03596010533326BIRMINGHAM HIP RESURFACING (BHR)Smith & Nephew, Inc.NXT2015-05-06