TENSOR SURGICAL, INC.

TENSOR SURGICAL, INC.

Address:6345 South Pecos Road Suite 212,Las Vegas,NV,89120,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Orthopedic Manual Surgical Instrument (LXH) (2)

Premarket Exempt

Yes

Clear

Tensor Surgical - 00850019153002 Catalog Number : 3000

Device Description : Reusable devices used as a kit to shuttle suture through bone

Device Class :

Duns Number: 051885419

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 2

Tensor Surgical VersaTip Suture Shuttle - 00850019153187 Catalog Number : 4010

Device Description : Device used for capturing suture and making repairs

Device Class : 1

Duns Number: 051885419

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

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