Primary Device ID | M697C06000620 |
NIH Device Record Key | 3f78d0f1-7264-4be1-917a-08febb4742c8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Axle Interspinous Fusion System |
Version Model Number | C060-0062 |
Company DUNS | 081224143 |
Company Name | Xtant Medical Holdings, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(888)886-9354 |
cs@xtantmedical.com | |
Phone | +1(888)886-9354 |
cs@xtantmedical.com | |
Phone | +1(888)886-9354 |
cs@xtantmedical.com | |
Phone | +1(888)886-9354 |
cs@xtantmedical.com | |
Phone | +1(888)886-9354 |
cs@xtantmedical.com | |
Phone | +1(888)886-9354 |
cs@xtantmedical.com | |
Phone | +1(888)886-9354 |
cs@xtantmedical.com | |
Phone | +1(888)886-9354 |
cs@xtantmedical.com | |
Phone | +1(888)886-9354 |
cs@xtantmedical.com | |
Phone | +1(888)886-9354 |
cs@xtantmedical.com | |
Phone | +1(888)886-9354 |
cs@xtantmedical.com | |
Phone | +1(888)886-9354 |
cs@xtantmedical.com | |
Phone | +1(888)886-9354 |
cs@xtantmedical.com | |
Phone | +1(888)886-9354 |
cs@xtantmedical.com | |
Phone | +1(888)886-9354 |
cs@xtantmedical.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M697C06000620 [Direct Marking] |
HIBCC | M697C06000621 [Primary] |
HTC | PLIERS, SURGICAL |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M697C06000620]
Moist Heat or Steam Sterilization
[M697C06000620]
Moist Heat or Steam Sterilization
[M697C06000620]
Moist Heat or Steam Sterilization
[M697C06000620]
Moist Heat or Steam Sterilization
[M697C06000620]
Moist Heat or Steam Sterilization
[M697C06000620]
Moist Heat or Steam Sterilization
[M697C06000620]
Moist Heat or Steam Sterilization
[M697C06000620]
Moist Heat or Steam Sterilization
[M697C06000620]
Moist Heat or Steam Sterilization
[M697C06000620]
Moist Heat or Steam Sterilization
[M697C06000620]
Moist Heat or Steam Sterilization
[M697C06000620]
Moist Heat or Steam Sterilization
[M697C06000620]
Moist Heat or Steam Sterilization
[M697C06000620]
Moist Heat or Steam Sterilization
[M697C06000620]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2021-06-03 |
Device Publish Date | 2016-11-01 |
M697X0806040X1 | 6.0 X 40mm, IRIX-A, RESCUE SCREW, CE MARKED |
M697X08060401 | 6.0 X 40mm, IRIX-A, RESCUE SCREW |
M697X0806035X1 | 6.0 X 35mm, IRIX-A, RESCUE SCREW, CE MARKED |
M697X08060351 | 6.0 X 35mm, IRIX-A, RESCUE SCREW |
M697X0806030X1 | 6.0 X 30mm, IRIX-A, RESCUE SCREW, CE MARKED |
M697X08060301 | 6.0 X 30mm, IRIX-A, RESCUE SCREW |
M697X0806025X1 | 6.0 X 25mm, IRIX-A, RESCUE SCREW, CE MARKED |
M697X08060251 | 6.0 X 25mm, IRIX-A, RESCUE SCREW |
M697X0805540STX1 | 5.5 X 40mm, IRIX-A, SELF TAPPING SCREW, CE MARKED |
M697X0805540ST1 | 5.5 X 40mm, IRIX-A, SELF TAPPING SCREW |
M697X0805540SDX1 | 5.5 X 40mm, IRIX-A, SELF DRILLING SCREW, CE MARKED |
M697X0805540SD1 | 5.5 X 40mm, IRIX-A, SELF DRILLING SCREW |
M697X0805535STX1 | 5.5 X 35mm, IRIX-A, SELF TAPPING SCREW, CE MARKED |
M697X0805535ST1 | 5.5 X 35mm, IRIX-A, SELF TAPPING SCREW |
M697X0805535SDX1 | 5.5 X 35mm, IRIX-A, SELF DRILLING SCREW, CE MARKED |
M697X0805535SD1 | 5.5 X 35mm, IRIX-A, SELF DRILLING SCREW |
M697X0805530STX1 | 5.5 X 30mm, IRIX-A, SELF TAPPING SCREW, CE MARKED |
M697X0805530ST1 | 5.5 X 30mm, IRIX-A, SELF TAPPING SCREW |
M697X0805530SDX1 | 5.5 X 30mm, IRIX-A, SELF DRILLING SCREW, CE MARKED |
M697X0805530SD1 | 5.5 X 30mm, IRIX-A, SELF DRILLING SCREW |
M697X0805525STX1 | 5.5 X 25mm, IRIX-A, SELF TAPPING SCREW, CE MARKED |
M697X0805525ST1 | 5.5 X 25mm, IRIX-A, SELF TAPPING SCREW |
M697X0805525SDX1 | 5.5 X 25mm, IRIX-A, SELF DRILLING SCREW, CE MARKED |
M697X0805525SD1 | 5.5 X 25mm, IRIX-A, SELF DRILLING SCREW |
M697X08042301912TPC1 | IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 12°, 19mm, PC |
M697X08042301912T1 | IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 12°, 19mm |
M697X08042301912STRX1 | IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 19mm (STERILE), CE MARKED |
M697X08042301912STR1 | IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 19mm (STERILE) |
M697X08042301912PCSTRX1 | IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 19mm, PC (STERILE), CE MARKED |
M697X08042301912PCSTR1 | IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 19mm, PC (STERILE) |
M697X08042301908TPC1 | IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 8°, 19mm, PC |
M697X08042301908T1 | IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 8°, 19mm |
M697X08042301908STRX1 | IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 19mm (STERILE), CE MARKED |
M697X08042301908STR1 | IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 19mm (STERILE) |
M697X08042301908PCSTRX1 | IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 19mm, PC (STERILE), CE MARKED |
M697X08042301908PCSTR1 | IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 19mm, PC (STERILE) |
M697X08042301712TPC1 | IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 12°, 17mm, PC |
M697X08042301712T1 | IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 12°, 17mm |
M697X08042301712STRX1 | IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 17mm (STERILE), CE MARKED |
M697X08042301712STR1 | IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 17mm (STERILE) |
M697X08042301712PCSTRX1 | IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 17mm, PC (STERILE), CE MARKED |
M697X08042301712PCSTR1 | IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 17mm, PC (STERILE) |
M697X08042301708TPC1 | IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 8°, 17mm, PC |
M697X08042301708T1 | IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 8°, 17mm |
M697X08042301708STRX1 | IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 17mm (STERILE), CE MARKED |
M697X08042301708STR1 | IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 17mm (STERILE) |
M697X08042301708PCSTRX1 | IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 17mm, PC (STERILE), CE MARKED |
M697X08042301708PCSTR1 | IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 17mm, PC (STERILE) |
M697X08042301512TPC1 | IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 12°, 15mm, PC |
M697X08042301512T1 | IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 12°, 15mm |