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510(k) Data Aggregation
K Number
K960988Device Name
LACTOSORB TRAUMA PLATING SYSTEM
Manufacturer
POLY-MEDICS,INC.
Date Cleared
1996-04-10
(34 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
POLY-MEDICS,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LactoSorb® Trauma Plating System is indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton.
- Comminuted fractures of the naso-ethmoidal and l. infraorbital areas.
- 2. Comminuted fractures of the frontal sinus wall.
- 3. Trauma of the midface or craniofacial skeleton.
- 4 . Reconstructive procedures of the midface or craniofacial skeleton.
This system is not designed for use in the mandible and/or full load bearing procedures.
Device Description
The LactoSorb® implants are made of bioresorbable and biocompatible polymer that have been used in surqical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLA/PGA) acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. The safety of PLA/PGA material has been well documented since the early 1970's when the FDA first approved the use of resorbable PLA/PGA sutures. The exact same LactoSorb® material has been implanted in for over 10 years in Poly humans Surqiclip® device manufactured by United States Surgical Corporation. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissue.
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K Number
K955729Device Name
LACTOSORB TRAUMA PLATING SYSTEM
Manufacturer
POLY-MEDICS,INC.
Date Cleared
1996-02-14
(58 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
POLY-MEDICS,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K954443Device Name
LACTOSORB SUTURE ANCHOR
Manufacturer
POLY-MEDICS,INC.
Date Cleared
1996-01-31
(128 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
POLY-MEDICS,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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