FDA.reportPublic FDA data

Graft Preparation Board

Primary DI
00887868511080
Brand
Graft Preparation Board
Company
Biomet Orthopedics, LLC
Model
904102
Catalog number
904102
Published
2021-12-17
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
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
00887868511080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868511080008878685110808878685110800887868511080

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament graft preparation stationAn assembly of devices designed to provide the operator with a workstation for the preparation and pretensioning of a ligament and/or tendon graft prior to implantation. It typically consists of a work base to provide a stable platform on which the graft can be treated, various types of adjustable and fixed posts including soft tissue clamps and tensioning devices, a graft sizing block, and tools to hold and tension a graft (e.g., an Allen key). It may be used for a variety of bone-tendon-bone and soft tissue grafts such as semitendinosus patellar tendon, quadriceps tendon, or patellar tendon grafts for anterior cruciate ligament (ACL) reconstruction. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

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