RESTORIS PST

Primary DI
00848486008345
Brand
RESTORIS PST
Company
MAKO SURGICAL CORP.
Model
186002-48
Catalog number
186002-48
Device description
Acetabular Shell, Cluster Hole
Published
2015-09-24
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

Product Codes#

Code, Name table
CodeName
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
OQGHip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
OQHHip, semi-constrained, cemented, metal/polymer + additive, cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOrthopedic2
OQHHip, Semi-Constrained, Cemented, Metal/Polymer + Additive, CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112802000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112802000PIPELINE TOTAL HIP SYSTEMPipeline Orthopedics2012-03-09OQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848486008345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848486008345008484860083458484860083450848486008345

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular shellA sterile, implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
175239677
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327594829Common Shoulder Driver1906601906602026-05-21
07613327595543Mako2906512906512026-05-21
07613327579888N/A7000015775787000015775782024-08-07
07613327595505Mako Glenoid RetractorSmall1906652026-01-08
07613327625868INSTRUMENT7000021128907000021128902024-10-04
07613327624304NA2299992299992024-09-18
07613327395280NA2199992199992020-12-15
00848486021702RIO2038662038662016-09-24
00848486022211NA2071102071102016-09-24
00848486023249NA2099272099272016-09-24
00848486030407NA2099992099992016-09-24
07613327627725MakoShoulder 1.0+TKA 2.0.1+TKA 1.0.3+THA 4.17000028873152026-03-10
07613327683653Shoulder 1.5 Installation Disk7000043787467000043787462026-03-03
00848486000349RESTORIS180320-2180320-22015-09-24
00848486000356RESTORIS180320-1180320-12015-09-24
00848486000370RESTORIS180320-4180320-42015-09-24
00848486000387RESTORIS180320-5180320-52015-09-24
00848486000394RESTORIS180320-6180320-62015-09-24
00848486000400RESTORIS1804021804022015-09-24
00848486000417RESTORIS1804031804032015-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07611996075038SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996095609SLR-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996095616SLR-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996095623SLR-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996095654SLR-PLUSSmith & Nephew, Inc.JDI2016-08-19
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07611996013788SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996013795SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996013849SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
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07611996081077SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996081084SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
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07611996081107SL-PLUSSmith & Nephew, Inc.JDI2015-11-25