FDA.reportPublic FDA data

Oxford Partial Knee System

Primary DI
05019279313167
Brand
Oxford Partial Knee System
Company
Biomet Uk Ltd
Model
32-422509
Catalog number
32-422509
Published
2020-05-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05019279313167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05019279313167050192793131675019279313167

GMDN Terms#

Term, Definition table
TermDefinition
Leg procedure positionerA preformed device (e.g., holder, sling, cushion, foam pad, wedge, multi-jointed structure) designed to be attached to an operating table to stabilize a patient's leg (e.g., thigh, knee, ankle) for adequate positioning and support of the body part during a medical/surgical procedure (e.g., orthopaedic surgery, examination, office procedure). It is typically padded to avoid damage of the skin/muscles/nerves, and components for attachment to the operating/examination table are typically included. This is a reusable device.

Device Sizes#

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

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
219322575
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024683808Oxford® Partial Knee System5122111155122111152026-04-09
00889024683815Oxford® Partial Knee System5122111505122111502026-04-09
00889024683181Oxford® Partial Knee System1122111001122111002026-04-03
00889024683198Oxford® Partial Knee System1122112001122112002026-04-03
00889024683204Oxford® Partial Knee System1122113001122113002026-04-03
00889024683211Oxford® Partial Knee System1122114001122114002026-04-03
00889024683228Oxford® Partial Knee System1122115001122115002026-04-03
00889024683235Oxford® Partial Knee System1122116001122116002026-04-03
00889024683242Oxford® Partial Knee System1122117001122117002026-04-03
00889024683259Oxford® Partial Knee System1122211001122211002026-04-03
00889024683266Oxford® Partial Knee System1122212001122212002026-04-03
00889024683273Oxford® Partial Knee System1122213001122213002026-04-03
00889024683280Oxford® Partial Knee System1122214001122214002026-04-03
00889024683297Oxford® Partial Knee System1122215001122215002026-04-03
00889024683303Oxford® Partial Knee System1122216001122216002026-04-03
00889024683310Oxford® Partial Knee System1122217001122217002026-04-03
00889024683327Oxford® Partial Knee System1123111001123111002026-04-03
00889024683334Oxford® Partial Knee System1123112001123112002026-04-03
00889024683341Oxford® Partial Knee System1123113001123113002026-04-03
00889024683358Oxford® Partial Knee System1123114001123114002026-04-03

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Primary DI, Brand, Company table
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