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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cuff, nerve
Regulation Description Nerve cuff.
Product CodeJXI
Regulation Number 882.5275
Device Class 2


Premarket Reviews
ManufacturerDecision
ALAFAIR BIOSCIENCES INC
  SUBSTANTIALLY EQUIVALENT 1
AXOGEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDOVENT GMBH
  SUBSTANTIALLY EQUIVALENT 1
MONARCH BIOIMPLANTS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 9 9
2018 6 6
2019 10 10
2020 5 5
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11 11
Insufficient Information 4 4
Appropriate Term/Code Not Available 4 4
Device Operates Differently Than Expected 3 3
No Apparent Adverse Event 2 2
Device Appears to Trigger Rejection 2 2
Device Expiration Issue 2 2
Patient-Device Incompatibility 2 2
Material Disintegration 1 1
Failure to Fold 1 1
Inadequacy of Device Shape and/or Size 1 1
Use of Device Problem 1 1
Expiration Date Error 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inflammation 6 6
Swelling 5 5
No Known Impact Or Consequence To Patient 4 4
Numbness 3 3
Unspecified Infection 3 3
Synovitis 3 3
Injury 3 3
Seroma 3 3
Erythema 2 2
Reaction 2 2
Wound Dehiscence 2 2
No Code Available 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Post Operative Wound Infection 1 1
Fibrosis 1 1
Host-Tissue Reaction 1 1
Abscess 1 1
Adhesion(s) 1 1
Bacterial Infection 1 1
Pain 1 1
Staphylococcus Aureus 1 1
Scar Tissue 1 1
Tingling 1 1
Granuloma 1 1
Failure of Implant 1 1
Skin Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. III Mar-11-2020
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