FDA.reportPublic FDA data

Table Tensioner

Primary DI
00887868511073
Brand
Table Tensioner
Company
Biomet Orthopedics, LLC
Model
904101
Catalog number
904101
Published
2021-07-23
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
00887868511073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868511073008878685110738878685110730887868511073

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic graft tensioner, reusableA hand-held, manual surgical instrument intended to be used during an open-surgery procedure [e.g., acromioclavicular joint repair, anterior cruciate ligament (ACL) reconstruction] to apply appropriate tension to a ligament graft/prosthesis, or flexible cord, to remove slack and facilitate adequate positioning of the device during implantation; it may also be used to apply tension to flexible instruments used during the procedure (e.g., graft sizer or gauge). Tension is applied to the graft after one end of the graft has been secured. The device is typically made of metal and in the form of a shaft with distal prongs. 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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00880304233164Biomet® Knee System1418781418782015-10-24
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00880304233188Biomet® Knee System1418821418822015-10-24
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00880304433410Vanguard® Knee System1841811841812015-10-24
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