INFrame™ Implant 2.0mm x 14mm
ACUMED - EXINF922014
Device Description
A non-bioabsorbable, rigid rod of fixed length intended to be implanted into the intramedullary canal of a bone in the hand (i.e., phalangeal, metacarpal) for fracture fixation; it is not intended to extend beyond the joint to an adjacent bone (i.e., not intended for arthrodesis/joint fusion). It is made of metal and may have a smooth or threaded external surface. Devices associated with implantation (e.g., bone screws) may be included with the nail. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: HWC
Device Name: Screw, Fixation, Bone
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: 888.3040
Third Party Flag: N
Medical Specialty: OR
Device Identifiers
Device Id: 10806378123887
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
