OSS™ Orthopedic Salvage System 161002

GUDID 00889024703285

Biomet Orthopedics, LLC

Knee arthroplasty wedge
Primary Device ID00889024703285
NIH Device Record Keyf55c8ee4-5a19-4379-bc3e-0960363810ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSS™ Orthopedic Salvage System
Version Model Number161002
Catalog Number161002
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024703285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-10
Device Publish Date2025-12-02

On-Brand Devices [OSS™ Orthopedic Salvage System]

00887868267253151871
00887868267246151870
00887868267239151869
00887868267222151868
00887868267215151867
00887868267208151866
00887868267192151865
00887868267185151864
00887868267178151863
00887868267161151862
00887868267154151861
00887868251856CP102848
00887868251849CP102847
00887868251832CP102846
00887868251825CP102845
00887868251818CP102844
00887868251801CP102843
00887868251795CP102840
00887868251788CP102839
00887868251771CP102838
00880304240056150489
00889024703339RD122064
00889024703322RD122063
00889024703315RD122062
00889024703292RD122060
00889024703285161002
00889024703261150452

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