Search Results
Found 11 results
510(k) Data Aggregation
K Number
K002413Device Name
ULTRASORB SUTURE ANCHOR
Manufacturer
LI MEDICAL TECHNOLOGIES, INC.
Date Cleared
2000-09-19
(43 days)
Product Code
MAI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
LI MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993373Device Name
ROTORBLADE SUTURE ANCHOR
Manufacturer
LI MEDICAL TECHNOLOGIES, INC.
Date Cleared
1999-10-27
(20 days)
Product Code
MAI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
LI MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Shoulder: rotator cuff repair
Device Description
Made from surgical grade PLL (homopolymer poly (L(-)-lactide), the LM Anchor is designed as a propeller blade type anchor device through which suture is passed to provide a means for soft tissue to bone attachment.
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K Number
K992938Device Name
ROTORBLADE SUTURE ANCHOR
Manufacturer
LI MEDICAL TECHNOLOGIES, INC.
Date Cleared
1999-09-23
(23 days)
Product Code
MAI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
LI MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Shoulder - rotator cuff repair
Device Description
Made from surgical grade PLL (homopolymer poly (L(-) -lactide), the LM Anchor is designed as a propeller blade type anchor device through which suture is passed to provide a means for soft tissue to bone attachment.
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K Number
K983435Device Name
ROTORBLADE
Manufacturer
LI MEDICAL TECHNOLOGIES, INC.
Date Cleared
1999-04-29
(212 days)
Product Code
MAI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
LI MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Shoulder: rotator cuff repair
Device Description
Made from surgical grade PLL (homopolymer poly (L(-)-lactide), the LM Anchor is designed as a propeller blade type anchor device through which suture is passed to provide a means for soft tissue to bone attachment.
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K Number
K981755Device Name
LM ANCHOR
Manufacturer
LI MEDICAL TECHNOLOGIES, INC.
Date Cleared
1998-07-13
(56 days)
Product Code
MBI, GAT, HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
LI MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Shoulder (bankart repair, rotator cuff repair, SLAP lesion, acromio-clavicular separation, biceps tenodesis, deltoid repair, capsular shift reconstruction, capsulolabral reconstruction), Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, ulnar collateral ligament, radial collateral ligament), Knee (medial collateral ligament, lateral collateral ligament, patellar tendon, patellar ligament avulsions, posterior oblique ligament, joint capsule to tibia, iliotibial band tenodesis).
Device Description
Made from surgical grade stainless steel (316L), the LM Anchor is designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment.
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K Number
K981764Device Name
LM ANCHOR
Manufacturer
LI MEDICAL TECHNOLOGIES, INC.
Date Cleared
1998-07-13
(55 days)
Product Code
MBI, GAT, HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
LI MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Shoulder - bankart repair
Hand/wrist - ulnar or lateral collateral ligament reconstruction, scapholunate ligament reconstruction, PIP collateral ligament, profundus tendon reattachment
Skull - lateral canthoplasty
Foot/ankle - hallux valgus reconstruction, midfoot reconstructions
Device Description
Made from surgical grade stainless steel (316L), the LM Anchor is designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment.
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K Number
K963288Device Name
LM BONE ANCHOR
Manufacturer
LI MEDICAL TECHNOLOGIES, INC.
Date Cleared
1996-11-13
(84 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
LI MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bladder neck suspension for female urinary incontinence due to urethral hypermobility. Fixation in pubic bone for the purpose of bladder neck suspension using USP #2 Class I, non-absorbable, synthetic suture (e.g., polypropylene). A minimum of two LM Anchors should be used in this (modified MMK, Raz, or Stamey, i.e., Benderev) procedure.
Device Description
Made from surgical grade stainless steel (316L) or titanium (6A1-4V ELI), the LM Anchor Products are designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment.
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K Number
K963812Device Name
LM BONE ANCHOR (ORTHOPEDICS)
Manufacturer
LI MEDICAL TECHNOLOGIES, INC.
Date Cleared
1996-11-12
(64 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
LI MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
UltraFix RC: Shoulder (rotator cuff repair)
UltraFix Mini: Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, ulnar collateral ligament, radial collateral ligament)
UltraFix: Shoulder (bankart repair, rotator cuff repair, SLAP lesion, acromio-clavicular separation, biceps tenodesis, deltoid repair, capsular shift reconstruction, capsulolabral reconstruction), Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, ulnar collateral ligament, radial collateral ligament), Knee (medial collateral ligament, lateral collateral ligament, patellar tendon, patellar ligament avulsions, posterior oblique ligament, joint capsule to tibia, iliotibial band tenodesis).
Device Description
Made from surgical grade stainless steel (316L) or titanium (6A1-4V ELI), the LM Anchor Products are designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment.
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K Number
K960825Device Name
LM ANCHOR OR OTHER PROPRIETARY NAME
Manufacturer
LI MEDICAL TECHNOLOGIES, INC.
Date Cleared
1996-04-30
(61 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
LI MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Shoulder (bankart repair, rotator cuff repair, SLAP lesion, acromio-clavicular separation, biceps tenodesis, deltoid repair, capsular shift reconstruction, capsulolabral reconstruction), Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, tennis elbow, ulnar collateral ligament, radial collateral ligament), Knee (medial collateral ligament, lateral collateral ligament, patellar tendon, patellar ligament avulsions, posterior oblique ligament, joint capsule to tibia, iliotibial band tenodesis), Bladder Neck Suspension.
Device Description
Made from surgical grade stainless steel (316L), the LM Anchor is designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment.
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K Number
K960439Device Name
LM BONE ANCHOR
Manufacturer
LI MEDICAL TECHNOLOGIES, INC.
Date Cleared
1996-04-18
(78 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
LI MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Shoulder (bankart repair, rotator cuff repair, SLAP lesion, acromio-clavicular separation, biceps tenodesis, deltoid repair, capsular shift reconstruction, capsulolabral reconstruction), Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, tennis elbow, ulnar collateral ligament, radial collateral ligament), Knee (medial collateral ligament, lateral collateral ligament, patellar tendon, patellar ligament avulsions, posterior oblique ligament, joint capsule to tibia, iliotibial band tenodesis).
Device Description
Made from surgical grade stainless steel (316L), the LM Anchor is designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment.
Ask a Question
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