Reliance Anterior Cervical Plate System 4-01-015

GUDID 00842566103029

RACP Single Level Plate, 15

RELIANCE MEDICAL SYSTEMS, LLC

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID00842566103029
NIH Device Record Keye0c5a918-ccf8-4447-88a0-5d0eeddba14b
Commercial Distribution StatusIn Commercial Distribution
Brand NameReliance Anterior Cervical Plate System
Version Model Number4-01-015
Catalog Number4-01-015
Company DUNS064885444
Company NameRELIANCE MEDICAL SYSTEMS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net
Phone801-295-3280
Emailinfo@reliance-medical.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100842566103029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842566103029]

Moist Heat or Steam Sterilization

[00842566103029]

Moist Heat or Steam Sterilization

[00842566103029]

Moist Heat or Steam Sterilization

[00842566103029]

Moist Heat or Steam Sterilization

[00842566103029]

Moist Heat or Steam Sterilization

[00842566103029]

Moist Heat or Steam Sterilization

[00842566103029]

Moist Heat or Steam Sterilization

[00842566103029]

Moist Heat or Steam Sterilization

[00842566103029]

Moist Heat or Steam Sterilization

[00842566103029]

Moist Heat or Steam Sterilization

[00842566103029]

Moist Heat or Steam Sterilization

[00842566103029]

Moist Heat or Steam Sterilization

[00842566103029]

Moist Heat or Steam Sterilization

[00842566103029]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-09

On-Brand Devices [Reliance Anterior Cervical Plate System]

00842566104163RACP 4.5 Self-Tapping, Variable Screw, 18
00842566104156RACP 4.5 Self-Tapping, Variable Screw, 16
00842566104149RACP 4.5 Self-Tapping, Variable Screw, 14
00842566104132RACP 4.5 Self-Tapping, Variable Screw, 12
00842566104125RACP 4.5 Self-Tapping, Fixed Screw, 18
00842566104118RACP 4.5 Self-Tapping, Fixed Screw, 16
00842566104101RACP 4.5 Self-Tapping, Fixed Screw, 14
00842566104095RACP 4.5 Self-Tapping, Fixed Screw, 12
00842566104088RACP 4.5 Self-Drilling, Variable Screw, 18
00842566104071RACP 4.5 Self-Drilling, Variable Screw, 16
00842566104064RACP 4.5 Self-Drilling, Variable Screw, 14
00842566104057RACP 4.5 Self-Drilling, Variable Screw, 12
00842566104040RACP 4.5 Self-Drilling, Fixed Screw, 18
00842566104033RACP 4.5 Self-Drilling, Fixed Screw, 16
00842566104026RACP 4.5 Self-Drilling, Fixed Screw, 14
00842566104019RACP 4.5 Self-Drilling, Fixed Screw, 12
00842566104002RACP 4.25 Self-Tapping, Variable Screw, 18
00842566103999RACP 4.25 Self-Tapping, Variable Screw, 16
00842566103982RACP 4.25 Self-Tapping, Variable Screw, 14
00842566103975RACP 4.25 Self-Tapping, Variable Screw, 12
00842566103968RACP 4.25 Self-Tapping, Fixed Screw, 18
00842566103951RACP 4.25 Self-Tapping, Fixed Screw, 16
00842566103944RACP 4.25 Self-Tapping, Fixed Screw, 14
00842566103937RACP 4.25 Self-Tapping, Fixed Screw, 12
00842566103920RACP 4.25 Self-Drilling, Variable Screw, 18
00842566103913RACP 4.25 Self-Drilling, Variable Screw, 16
00842566103906RACP 4.25 Self-Drilling, Variable Screw, 14
00842566103890RACP 4.25 Self-Drilling, Variable Screw, 12
00842566103883RACP 4.25 Self-Drilling, Fixed Screw, 18
00842566103876RACP 4.25 Self-Drilling, Fixed Screw, 16
00842566103869RACP 4.25 Self-Drilling, Fixed Screw, 14
00842566103852RACP 4.25 Self-Drilling, Fixed Screw, 12
00842566103845RACP 4.0 Self-Tapping, Variable Screw, 18
00842566103838RACP 4.0 Self-Tapping, Variable Screw, 16
00842566103821RACP 4.0 Self-Tapping, Variable Screw, 14
00842566103814RACP 4.0 Self-Tapping, Variable Screw, 12
00842566103807RACP 4.0 Self-Tapping, Fixed Screw, 18
00842566103791RACP 4.0 Self-Tapping, Fixed Screw, 16
00842566103784RACP 4.0 Self-Tapping, Fixed Screw, 14
00842566103777RACP 4.0 Self-Tapping, Fixed Screw, 12
00842566103760RACP 4.0 Self-Drilling, Variable Screw, 18
00842566103753RACP 4.0 Self-Drilling, Variable Screw, 16
00842566103746RACP 4.0 Self-Drilling, Variable Screw, 14
00842566103739RACP 4.0 Self-Drilling, Variable Screw, 12
00842566103722RACP 4.0 Self-Drilling, Fixed Screw, 18
00842566103715RACP 4.0 Self-Drilling, Fixed Screw, 16
00842566103708RACP 4.0 Self-Drilling, Fixed Screw, 14
00842566103692RACP 4.0 Self-Drilling, Fixed Screw, 12
00842566103685RACP Five-Level Plate, 105
00842566103678RACP Five-Level Plate, 100
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.