X90 Pedicle Screw System

GUDID M697N600003201

5.5mm x 55mm Screw Assembly

Xtant Medical Holdings, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDM697N600003201
NIH Device Record Keyf8106467-7d58-451d-bbf1-f306b45b0c94
Commercial Distribution StatusIn Commercial Distribution
Brand NameX90 Pedicle Screw System
Version Model NumberN60000320
Company DUNS081224143
Company NameXtant Medical Holdings, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com

Device Dimensions

Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM697N600003201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M697N600003201]

Moist Heat or Steam Sterilization

[M697N600003201]

Moist Heat or Steam Sterilization

[M697N600003201]

Moist Heat or Steam Sterilization

[M697N600003201]

Moist Heat or Steam Sterilization

[M697N600003201]

Moist Heat or Steam Sterilization

[M697N600003201]

Moist Heat or Steam Sterilization

[M697N600003201]

Moist Heat or Steam Sterilization

[M697N600003201]

Moist Heat or Steam Sterilization

[M697N600003201]

Moist Heat or Steam Sterilization

[M697N600003201]

Moist Heat or Steam Sterilization

[M697N600003201]

Moist Heat or Steam Sterilization

[M697N600003201]

Moist Heat or Steam Sterilization

[M697N600003201]

Moist Heat or Steam Sterilization

[M697N600003201]

Moist Heat or Steam Sterilization

[M697N600003201]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-06-03
Device Publish Date2015-09-28

On-Brand Devices [X90 Pedicle Screw System]

M697N607555SDDL1Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 55
M697N607555SD1Assembly, X90, 7.5 x 55 Self-Drilling Screw
M697N607550SDDL1Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 50
M697N607550SD1Assembly, X90, 7.5 x 50 Self-Drilling Screw
M697N607545SDDL1Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 45
M697N607545SD1Assembly, X90, 7.5 x 45 Self-Drilling Screw
M697N607540SDDL1Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 40
M697N607540SD1Assembly, X90, 7.5 x 40 Self-Drilling Screw
M697N607535SDDL1Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 35
M697N607535SD1Assembly, X90, 7.5 x 35 Self-Drilling Screw
M697N607530SDDL1Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 30
M697N607530SD1Assembly, X90, 7.5 x 30 Self-Drilling Screw
M697N606555SDDL1Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 55
M697N606555SD1Assembly, X90, 6.5 x 55 Self-Drilling Screw
M697N606550SDDL1Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 50
M697N606550SD1Assembly, X90, 6.5 x 50 Self-Drilling Screw
M697N606545SDDL1Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 45
M697N606545SD1Assembly, X90, 6.5 x 45 Self-Drilling Screw
M697N606540SDDL1Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 40
M697N606540SD1Assembly, X90, 6.5 x 40 Self-Drilling Screw
M697N606535SDDL1Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 35
M697N606535SD1Assembly, X90, 6.5 x 35 Self-Drilling Screw
M697N606530SDDL1Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 30
M697N606530SD1Assembly, X90, 6.5 x 30 Self-Drilling Screw
M697N605555SDDL1Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 55
M697N605555SD1Assembly, X90, 5.5 x 55 Self-Drilling Screw
M697N605550SDDL1Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 50
M697N605550SD1Assembly, X90, 5.5 x 50 Self-Drilling Screw
M697N605545SDDL1Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 45
M697N605545SD1Assembly, X90, 5.5 x 45 Self-Drilling Screw
M697N605540SDDL1Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 40
M697N605540SD1Assembly, X90, 5.5 x 40 Self-Drilling Screw
M697N605535SDDL1Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 35
M697N605535SD1Assembly, X90, 5.5 x 35 Self-Drilling Screw
M697N605530SDDL1Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 30
M697N605530SD1Assembly, X90, 5.5 x 30 Self-Drilling Screw
M697N600022010Sterilization Case, 5.5mm Rod, Instrument
M697N6000220005.5mm Rod Instrument Set
M697N600021050Cross Connector Caddy, X90
M697N600021040Rod Caddy, X90
M697N600021030Sterilization Case, X90, Instrument
M697N600021020Sterilization Case, X90, Implant
M697N600016200Twist Driver, Assembly
M697N600016100Flex Locking Screwdriver, X90, Assy
M697N600015780CAM SCREWDRIVER THUMB WHEEL
M697N600015770CAM SCREWDRIVER FORK SLEEVE
M697N600015760CAM SCREWDRIVER HEX SHAFT
M697N600015750CAM SCREWDRIVER ASSEMBLY
M697N600015540FINAL LOCKING WRENCH, 1/4" SQUARE
M697N600015530PROVISIONAL LOCKING WRENCH, 1/4" SQUARE
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.