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510(k) Data Aggregation
K Number
K111971Device Name
SYNDE-LOCK SYNDESMOSIS REPAIR KIT
Manufacturer
TARSUS MEDICAL INC.
Date Cleared
2012-01-23
(196 days)
Product Code
HWC, HTN
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
TARSUS MEDICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tarsus Synde-Lock Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma.
Device Description
The Synde-Lock™ Syndesmosis Repair Kit contains an implant designed as two bone anchors, one a stainless steel screw and the other a PEEK T-nut, connected by a distribution bridge comprised of UHMWPE suture and a threaded PEEK rod. The stainless steel screw is pre-threaded with the UHMWPE suture section of the distribution bridge. The PEEK T-nut engages the threads of the PEEK section of the distribution bridge allowing the effective length of the bridge to be shortened. A clipper is also contained in the kit to cut away excess distribution bridge material, once the implant is in place. The Tarsus Synde-Lock Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma.
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K Number
K110800Device Name
META-LOCK SUTURE ANCHOR SYSTEM
Manufacturer
TARSUS MEDICAL INC.
Date Cleared
2011-09-27
(189 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
TARSUS MEDICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tarsus Medical Meta-Lock Suture Anchor System is intended for fixation of suture to bone for the indications listed below:
SHOULDER: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, Deltoid repair
ANKLE: Lateral instability, medial instability, achilles tendon repair/reconstruction, Midfoot reconstructions
FOOT: Hallux valgus reconstruction
WRIST: Scapholunate ligament
HAND: Ulnar or lateral collateral ligament reconstruction
ELBOW: Biceps tendon reattachment
KNEE: Extra capsular repairs; reattachment of : medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tendonesis; patellar ligament and tendon avulsions.
Device Description
The Meta-Lock™ Suture Anchor System is a suture anchor used for the reattachment of soft tissue to bone.
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