REFLECTION

Primary DI
03596010463302
Brand
REFLECTION
Company
Smith & Nephew, Inc.
Model
71332550
Catalog number
71332550
Device description
REFLECTION SPHERICAL HEAD SCREW 50MM
Published
2015-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211176000
K990666000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211176000Smith & Nephew Hip SystemsSmith & Nephew, Inc.2022-07-01LPH
K990666000HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELLSmith & Nephew, Inc.1999-08-06MEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010463302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010463302035960104633023596010463302

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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+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
07611996142334POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
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07611996142372POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142389POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142396POLARSTEMSmith & Nephew, Inc.MEH2016-09-01
07611996103410POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103434POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103489POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103496POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103502POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103519POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103533POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103540POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996152692POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103373POLARSTEMSmith & Nephew, Inc.MEH2016-07-22
07611996103380POLARSTEMSmith & Nephew, Inc.MEH2016-07-22
07611996103397POLARSTEMSmith & Nephew, Inc.MEH2016-07-22
07611996103403POLARSTEMSmith & Nephew, Inc.MEH2016-07-22
07613153071273RestorationHowmedica Osteonics Corp.MEH2015-09-24
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07613153071327RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071334RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071341RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071358RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071365RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071372RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071396RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071402RestorationHowmedica Osteonics Corp.MEH2015-09-24