Search Results
Found 2 results
510(k) Data Aggregation
K Number
K160304Device Name
OsteoBullet Compression Screw
Manufacturer
Phalanx Innovations
Date Cleared
2016-04-29
(85 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Phalanx Innovations
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OsteoBullet Compression Screw is intended to maintain alignment and fixation of bone fractures, non-unions, osteotomies, or arthrodeses of small bones in the hand and foot.
Device Description
The OsteoBullet Compression Screw has a wide range of diameters and lengths for use in a variety of fracture treatments. Implants are available as cannulated or non-cannulated and made from Titanium 6AL-4V ELI (ASTM F136) or Zeniva™ ZA-500 PEEK (ASTM F2026) and range in size from Ø3 to 7 mm in diameter and 16 to 105 mm in length. Implants are provided sterile and are for single use only. The system includes instrumentation to aid in delivery of the implants including drill guides, guide wires, depth gauge, manual drills, manual stop drills, taps, and drivers.
Ask a Question
K Number
K160194Device Name
StarFuse Interphalangeal Pin
Manufacturer
Phalanx Innovations
Date Cleared
2016-04-26
(90 days)
Product Code
HTY
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Phalanx Innovations
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The StarFuse Interphalangeal Pin is indicated for use with osteotomies, arthrodeses, and reconstruction procedures involving the correction of the lesser digits of the toes.
Device Description
The StarFuse Interphalangeal Pin is a fusion device available in a range of profile diameters and lengths as well as straight or pre-bent options. Implants are made from 316LVM Stainless Steel per ASTM F138 and range in size from 3 to 4 mm in diameter and 16 to 30 mm in length.
Ask a Question
Page 1 of 1