ORTHOPEDIC SALVAGE SYSTEM (OSS™) / ARCOS®

Primary DI
00880304683068
Brand
ORTHOPEDIC SALVAGE SYSTEM (OSS™) / ARCOS®
Company
Biomet Orthopedics, LLC
Model
110024552
Catalog number
110024552
Published
2018-10-19
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
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152621000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152621000OSS/Arcos IM Total Femur RodBiomet, Inc.2015-10-14JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304683068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304683068008803046830688803046830680880304683068

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868561368VersaNail®2810-13-0372810130372023-09-07
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24
00880304434363Vanguard® Knee System1842701842702015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404028001257SurgiCase PlannerMaterialise NVJWH2026-05-28
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07611996074918SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074925SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074956SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074963SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074970SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074987SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996075007SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996075021SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
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
07611996095661SLR-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996095685SLR-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996013788SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996013795SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996013849SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996014990BOFOR/EP-FIT PLUS/PROMOS/MPFSmith & Nephew, Inc.JDI2015-11-25
07611996045208MODULAR-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996065343SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996076394SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996081008SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996081022SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996081046SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996081077SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996081084SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996081091SL-PLUSSmith & Nephew, Inc.JDI2015-11-25