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510(k) Data Aggregation
K Number
K161191Device Name
Latera Absorbable Nasal Implant
Manufacturer
SPIROX, INC.
Date Cleared
2016-06-23
(57 days)
Product Code
NHB
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
SPIROX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spirox Latera Absorbable Nasal Implant is indicated for supporting nasal upper and lower lateral cartilage.
Device Description
The Spirox Latera Absorbable Nasal Implant System is intended to support cartilage in the nasal lateral wall. The System consists of the Latera Absorbable Nasal Implant) and Accessory Delivery Device (Delivery Device). The Implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and overall length of 24mm. The distal end of the Implant is forked to facilitate anchoring during implantation and the proximal end is narrower for increased flexibility. The disposable Delivery Device is comprised of a non-patient contacting handle assembly and a medical grade stainless steel 16 gauge delivery cannula. The Delivery Device enables placement of the Implant in a minimally invasive manner. The Latera Absorbable Nasal Implant and Accessory Delivery Device are provided sterile and are intended for single-use only.
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K Number
K152958Device Name
INEX Absorbable Nasal Implant
Manufacturer
SPIROX, INC.
Date Cleared
2015-12-04
(58 days)
Product Code
NHB
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
SPIROX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spirox INEX Absorbable Nasal Implant is indicated for supporting nasal upper and lower lateral cartilage.
Device Description
The Spirox INEX Absorbable Nasal Implant System is intended to support cartilage in the nasal lateral wall. The System consists of the INEX Absorbable Nasal Implant and accessory Delivery Tool. The implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and an overall length of 24mm. The distal end of the implant is forked to facilitate anchoring during implantation and the proximal end is narrower for increased flexibility. The disposable Delivery Tool is comprised of a non-patient contacting handle assembly and a medical grade stainless steel 16 gauge delivery cannula. The Delivery Tool enables placement of the implant in a minimally invasive manner. The INEX Absorbable Nasal Implant and accessory Delivery Tool are provided sterile and are intended for single-use only.
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K Number
K132920Device Name
SPIROX INEX DEVICE
Manufacturer
SPIROX, INC.
Date Cleared
2014-06-10
(266 days)
Product Code
NHB
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
SPIROX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spirox INEX absorbable implant is indicated for supporting nasal septal cartilage.
Device Description
The Spirox INEX implantable sheet is an absorbable device comprised of a poly (L-lactide) 70:30. The product is provided as a perforated sheet comprised of multiple "rod" like elements. The sheet is nominally 24.5 x 20.0 mm with a thickness of 1.1 mm. The bridge sections are nominally 3.0 x 1.9 mm and the voids are nominally 2.4 x 1.9 mm. The implant can be trimmed and shaped to dimensions suitable for the surgical need. The device is implanted using standard surgical tools and techniques The Spirox INEX implantable sheet is a sterile, single use device.
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