Primary Device ID | M697X0850108U1 |
NIH Device Record Key | 33e95b09-1598-4fe4-a8c2-45c9540311ab |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Xspan Laminoplasty Fixation System |
Version Model Number | X085-0108-U |
Company DUNS | 081224143 |
Company Name | Xtant Medical Holdings, Inc. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
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(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com | |
Phone | +1(937)847-8400 |
orders@x-spine.com |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Length | 8 Millimeter |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M697X0850108U1 [Primary] |
NQW | ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL |
Steralize Prior To Use | true |
Device Is Sterile | true |
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
[M697X0850108U1]
Radiation Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2021-06-03 |
Device Publish Date | 2016-04-08 |
M697X0853009STR1 | SCREW, 3.0mm x 9mm LONG, SELF-DRILLING |
M697X08530091 | SCREW, 3.0mm x 9mm LONG, SELF-DRILLING |
M697X0853008STR1 | SCREW, 3.0mm x 8mm LONG, SELF-DRILLING |
M697X08530081 | SCREW, 3.0mm x 8mm LONG, SELF-DRILLING |
M697X0853007STR1 | SCREW, 3.0mm x 7mm LONG, SELF-DRILLING |
M697X08530071 | SCREW, 3.0mm x 7mm LONG, SELF-DRILLING |
M697X0853006STR1 | SCREW, 3.0mm x 6mm LONG, SELF-DRILLING |
M697X08530061 | SCREW, 3.0mm x 6mm LONG, SELF-DRILLING |
M697X0853005STR1 | SCREW, 3.0mm x 5mm LONG, SELF-DRILLING |
M697X08530051 | SCREW, 3.0mm x 5mm LONG, SELF-DRILLING |
M697X0852609STR1 | SCREW, 2.6mm x 9mm LONG, SELF-DRILLING |
M697X08526091 | SCREW, 2.6mm x 9mm LONG, SELF-DRILLING |
M697X0852608STR1 | SCREW, 2.6mm x 8mm LONG, SELF-DRILLING |
M697X08526081 | SCREW, 2.6mm x 8mm LONG, SELF-DRILLING |
M697X0852607STR1 | SCREW, 2.6mm x 7mm LONG, SELF-DRILLING |
M697X08526071 | SCREW, 2.6mm x 7mm LONG, SELF-DRILLING |
M697X0852606STR1 | SCREW, 2.6mm x 6mm LONG, SELF-DRILLING |
M697X08526061 | SCREW, 2.6mm x 6mm LONG, SELF-DRILLING |
M697X0852605STR1 | SCREW, 2.6mm x 5mm LONG, SELF-DRILLING |
M697X08526051 | SCREW, 2.6mm x 5mm LONG, SELF-DRILLING |
M697X0850312H06RUSTR1 | 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT, UNSLOTTED |
M697X0850312H06RU1 | 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT, UNSLOTTED |
M697X0850312H06RSTR1 | 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT |
M697X0850312H06R1 | 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT |
M697X0850312H06LUSTR1 | 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED |
M697X0850312H06LU1 | 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED |
M697X0850312H06LSTR1 | 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT |
M697X0850312H06L1 | 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT |
M697X0850312H04RUSTR1 | 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 4mm THROAT, UNSLOTTED |
M697X0850312H04RU1 | 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 4mm THROAT, UNSLOTTED |
M697X0850312H04RSTR1 | 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 4mm THROAT |
M697X0850312H04R1 | 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 4mm THROAT |
M697X0850312H04LUSTR1 | 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED |
M697X0850312H04LU1 | 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED |
M697X0850312H04LSTR1 | 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT |
M697X0850312H04L1 | 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT |
M697X0850312F06RSTR1 | 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK & FIN, 6mm THROAT |
M697X0850312F06R1 | 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK & FIN, 6mm THROAT |
M697X0850312F06LSTR1 | 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK & FIN, 6mm THROAT |
M697X0850312F06L1 | 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK & FIN, 6mm THROAT |
M697X0850312F04RSTR1 | 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK & FIN, 4mm THROAT |
M697X0850312F04R1 | 12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK & FIN, 4mm THROAT |
M697X0850312F04LSTR1 | 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK & FIN, 4mm THROAT |
M697X0850312F04L1 | 12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK & FIN, 4mm THROAT |
M697X0850310H06RUSTR1 | 10mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT, UNSLOTTED |
M697X0850310H06RU1 | 10mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT, UNSLOTTED |
M697X0850310H06RSTR1 | 10mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT |
M697X0850310H06R1 | 10mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT |
M697X0850310H06LUSTR1 | 10mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED |
M697X0850310H06LU1 | 10mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED |