FDA.report

OXFORD UNICOMPARTMENTAL KNEE PHASE 3SPHERICAL CUTT

Primary DI
05019279784264
Brand
OXFORD UNICOMPARTMENTAL KNEE PHASE 3SPHERICAL CUTT
Company
Biomet Uk Ltd
Model
32-421062
Catalog number
32-421062
Published
2017-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05019279784264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05019279784264050192797842645019279784264

GMDN Terms

TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument designed to resect (cut out part of the bone) and precisely shape a specific area of bone for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). It is commonly called a mill or a reamer and is typically designed as either a preshaped or a solid cylindrical body with an end or circumferential cutting edge. It is attached to a shaft for manual or powered rotation and may be steered over a guide or spigot that has been inserted into the site to control the cutting action. It is typically made of a high-grade stainless steel alloy in varying sizes. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.c
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags

DUNS number
219322575
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05019279477333Oxford Partial Knee SystemFemoral Impactor32-42012732-4201272020-05-23
05019279905638OXFORD UNICOMPARTMENTAL KNEE PHASE 3TIBIAL IMPACTOR32-42093232-4209322020-05-23
05019279439935Oxford® Partial Knee System32-42297432-4229742020-05-23
05019279439942Oxford® Partial Knee System32-42297532-4229752020-05-23
05019279439959Oxford® Partial Knee System32-42297632-4229762020-05-23
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00887868259050Oxford® Partial Knee System1100317791100317792025-01-10
00887868354694Oxford® Partial Knee System1665701665702025-01-10
00887868354700Oxford® Partial Knee System1665711665712025-01-10
00887868354717Oxford® Partial Knee System1665721665722025-01-10
00887868354724Oxford® Partial Knee System1665731665732025-01-10
00887868354731Oxford® Partial Knee System1665741665742025-01-10
00887868354748Oxford® Partial Knee System1665751665752025-01-10
00887868354755Oxford® Partial Knee System1665761665762025-01-10
00887868354762Oxford® Partial Knee System1665771665772025-01-10
00887868354779Oxford® Partial Knee System1665781665782025-01-10
00887868354786Oxford® Partial Knee System1665791665792025-01-10
00887868354793Oxford® Partial Knee System1665801665802025-01-10
00887868354809Oxford® Partial Knee System1665811665812025-01-10
00887868354816Oxford® Partial Knee System1668451668452025-01-10

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