REFLECTION

Primary DI
03596010488190
Brand
REFLECTION
Company
Smith & Nephew, Inc.
Model
71332538
Catalog number
71332538
Device description
REFLECTION LOCKING HEAD PEG 35MM
Published
2015-08-30
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
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022556000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022556000REFLECTION MODIFIED ACETABULAR SHELLSSmith & Nephew, Inc.2002-08-28LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010488190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010488190035960104881903596010488190

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

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
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
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07611996098112POLARCUPSmith & Nephew, Inc.LPH2015-11-25
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07611996098136POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098143POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098150POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098174POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098501POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098518POLARCUPSmith & Nephew, Inc.LPH2015-11-25
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07611996111378POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111392POLARCUPSmith & Nephew, Inc.LPH2015-11-25
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07611996111422POLARCUPSmith & Nephew, Inc.LPH2015-11-25
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07611996111514POLARCUPSmith & Nephew, Inc.LPH2015-11-25
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07611996111552POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996112320POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996112351POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996112368POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996114638POLARCUPSmith & Nephew, Inc.LPH2015-11-25