FDA.reportPublic FDA data

BIRMINGHAM HIPTM RESURFACING

Primary DI
03596010503497
Brand
BIRMINGHAM HIPTM RESURFACING
Company
Smith & Nephew, Inc.
Model
901338
Catalog number
901338
Device description
BHR HEAD CENTRE CHECK JIG SZ 38
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
03596010503497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010503497035960105034973596010503497

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
03596010194534SYNERGY71306709713067092015-08-30
03596010194541SYNERGY71306710713067102015-08-30
03596010194558SYNERGY71306711713067112015-08-30
03596010194565SYNERGY71306712713067122015-08-30
03596010194572SYNERGY71306713713067132015-08-30
03596010194589SYNERGY71306714713067142015-08-30
03596010194596SYNERGY71306715713067152015-08-30
03596010194602SYNERGY71306716713067162015-08-30
03596010194619SYNERGY71306717713067172015-08-30
03596010194626SYNERGY71306718713067182015-08-30
03596010384935SYNERGY71306409713064092015-08-29
03596010384942SYNERGY71306410713064102015-08-29
03596010384966SYNERGY71306411713064112015-08-29
03596010384973SYNERGY71306412713064122015-08-29
03596010384980SYNERGY71306413713064132015-08-30
03596010384997SYNERGY71306414713064142015-08-30
03596010385000SYNERGY71306415713064152015-08-30
03596010385017SYNERGY71306416713064162015-08-30
03596010385024SYNERGY71306417713064172015-08-30
03596010385031SYNERGY71306418713064182015-08-30

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
03596010503503BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-11-25
03596010503510BIRMINGHAM 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