FDA.report

TESA Tensioner System

Primary DI
00850075235162
Brand
TESA Tensioner System
Company
Tesa Medical, Inc.
Model
90-TSA-333070
Catalog number
90-TSA-333070
Device description
MPFL Dock, reusable, 70mm
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850075235162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850075235162008500752351628500752351620850075235162

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
145004472
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
true
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
00850075235063TESA IF Screw System90-TSA-00010090-TSA-0001002026-05-26
00850075235070TESA Tensioner System90-TSA-00020090-TSA-0002002026-05-26
00850075235087TESA IF Screw System90-TSA-15001090-TSA-1500102026-05-26
00850075235094TESA IF Screw System90-TSA-15001590-TSA-1500152026-05-26
00850075235100TESA IF Screw System90-TSA-15011590-TSA-1501152026-05-26
00850075235117TESA IF Screw System90-TSA-15061090-TSA-1506102026-05-26
00850075235124TESA IF Screw System90-TSA-15062090-TSA-1506202026-05-26
00850075235131TESA Tensioner System90-TSA-31300090-TSA-3130002026-05-26
00850075235148TESA Tensioner System90-TSA-33200190-TSA-3320012026-05-26
00850075235155TESA Tensioner System90-TSA-33305090-TSA-3330502026-05-26
00850075235179TESA Tensioner System90-TSA-00025090-TSA-0002502026-05-26

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