OSS™ Orthopedic Salvage System 161001

GUDID 00889024703278

Biomet Orthopedics, LLC

Knee arthroplasty wedge
Primary Device ID00889024703278
NIH Device Record Key5986f881-badb-4129-8513-df161608a5c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSS™ Orthopedic Salvage System
Version Model Number161001
Catalog Number161001
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
GS100889024703278 [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 Date2025-12-17
Device Publish Date2025-12-09

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
00889024702028CP461012
00889024702011CP461011
0088902470200432-467295
00889024703308RD122061
00889024703278161001

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