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510(k) Data Aggregation
K Number
K991962Device Name
EIS DYNAMIC MEMORY STAPLES SYSTEM
Manufacturer
GROUPE LEPINE
Date Cleared
2000-01-10
(214 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
GROUPE LEPINE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Groupe Lepine EIS dynamic memory staples system was designed and is intended to be used for the fixation of fractures by compressing two bones together after a osteotomy. The staples are intended for bone fixation after corrective osteotomy of the big toe, interphangeal fusion, fractures of the scaphoid or small trauma injuries.
The indications for use of the screw system are as follows: to secure the two sections of bone after an osteotomy caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or arthritis secondary to a variety of diseases or anomalies or trauma fracture.
Device Description
EIS Dynamic Memory Staples System
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K Number
K991964Device Name
EIS THREADED SCREW FRACTURE FIXATION
Manufacturer
GROUPE LEPINE
Date Cleared
1999-12-20
(193 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
GROUPE LEPINE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Groupe Lepine EIS threaded compression screw system is intended to be used as a fixation screw of the first metatarsal after a corrective osteotomy, or for fixation of small bones after trauma fractures.
The indications for use of the screw system are as follows: to secure the two sections of bone after an osteotomy caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or arthritis secondary to a variety of diseases or anomalies, or trauma fractures.
Device Description
EIS Threaded Compression Screw System
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