Royal Oak Pedicle Screw System

GUDID 00812352020304

5.5mm Pedicle Screw Assembly Ø5.5x40mm

Royal Oak Medical Devices LLC

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00812352020304
NIH Device Record Keyefa98ed7-1f48-4940-8c09-08cde5e56c41
Commercial Distribution StatusIn Commercial Distribution
Brand NameRoyal Oak Pedicle Screw System
Version Model NumberPS5.5-5.5-40
Company DUNS017825896
Company NameRoyal Oak Medical Devices LLC
Device Count1
DM Exemptfalse
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

Phone248-853-1450
Emailcustomerservice@royaloakmed.com
Phone248-853-1450
Emailcustomerservice@royaloakmed.com
Phone248-853-1450
Emailcustomerservice@royaloakmed.com
Phone248-853-1450
Emailcustomerservice@royaloakmed.com
Phone248-853-1450
Emailcustomerservice@royaloakmed.com
Phone248-853-1450
Emailcustomerservice@royaloakmed.com
Phone248-853-1450
Emailcustomerservice@royaloakmed.com
Phone248-853-1450
Emailcustomerservice@royaloakmed.com
Phone248-853-1450
Emailcustomerservice@royaloakmed.com
Phone248-853-1450
Emailcustomerservice@royaloakmed.com
Phone248-853-1450
Emailcustomerservice@royaloakmed.com
Phone248-853-1450
Emailcustomerservice@royaloakmed.com
Phone248-853-1450
Emailcustomerservice@royaloakmed.com
Phone248-853-1450
Emailcustomerservice@royaloakmed.com
Phone248-853-1450
Emailcustomerservice@royaloakmed.com
Phone248-853-1450
Emailcustomerservice@royaloakmed.com
Phone248-853-1450
Emailcustomerservice@royaloakmed.com
Phone248-853-1450
Emailcustomerservice@royaloakmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100812352020304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00812352020304]

Moist Heat or Steam Sterilization

[00812352020304]

Moist Heat or Steam Sterilization

[00812352020304]

Moist Heat or Steam Sterilization

[00812352020304]

Moist Heat or Steam Sterilization

[00812352020304]

Moist Heat or Steam Sterilization

[00812352020304]

Moist Heat or Steam Sterilization

[00812352020304]

Moist Heat or Steam Sterilization

[00812352020304]

Moist Heat or Steam Sterilization

[00812352020304]

Moist Heat or Steam Sterilization

[00812352020304]

Moist Heat or Steam Sterilization

[00812352020304]

Moist Heat or Steam Sterilization

[00812352020304]

Moist Heat or Steam Sterilization

[00812352020304]

Moist Heat or Steam Sterilization

[00812352020304]

Moist Heat or Steam Sterilization

[00812352020304]

Moist Heat or Steam Sterilization

[00812352020304]

Moist Heat or Steam Sterilization

[00812352020304]

Moist Heat or Steam Sterilization

[00812352020304]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-20

On-Brand Devices [Royal Oak Pedicle Screw System]

00812352021318Royal Oak Pedicle Screw Instrument Set Case 2
00812352021301Royal Oak Pedicle Screw Instrument Set Case 1
00812352020564Straight Rod Ø5.5x90mm
00812352020557Straight Rod Ø5.5x80mm
00812352020540Straight Rod Ø5.5x70mm
00812352020533Straight Rod Ø5.5x50mm
00812352020526Straight Rod Ø5.5 x 400mm
00812352020519Straight Rod Ø5.5x40mm
00812352020502Straight Rod Ø5.5x200mm
00812352020496Straight Rod Ø5.5x180mm
00812352020489Straight Rod Ø5.5x150mm
00812352020472Straight Rod Ø5.5x120mm
00812352020465Straight Rod Ø5.5x110mm
00812352020458Straight Rod Ø5.5x100mm
008123520204415.5mm Pedicle Screw Assembly Ø7.5x55mm
008123520204345.5mm Pedicle Screw Assembly Ø7.5x50mm
008123520204275.5mm Pedicle Screw Assembly Ø7.5x45mm
008123520204105.5mm Pedicle Screw Assembly Ø7.5x40mm
008123520204035.5mm Pedicle Screw Assembly Ø7.5x35mm
008123520203975.5mm Pedicle Screw Assembly Ø7.5x30mm
008123520203805.5mm Pedicle Screw Assembly Ø6.5x55mm
008123520203735.5mm Pedicle Screw Assembly Ø6.5x50mm
008123520203665.5mm Pedicle Screw Assembly Ø6.5x45mm
008123520203595.5mm Pedicle Screw Assembly Ø6.5x40mm
008123520203425.5mm Pedicle Screw Assembly Ø6.5x35mm
008123520203355.5mm Pedicle Screw Assembly Ø6.5x30mm
008123520203285.5mm Pedicle Screw Assembly Ø5.5x50mm
008123520203115.5mm Pedicle Screw Assembly Ø5.5x45mm
008123520203045.5mm Pedicle Screw Assembly Ø5.5x40mm
008123520202985.5mm Pedicle Screw Assembly Ø5.5x35mm
008123520202815.5mm Pedicle Screw Assembly Ø4.5x50mm
008123520202745.5mm Pedicle Screw Assembly Ø4.5x45mm
008123520202675.5mm Pedicle Screw Assembly Ø4.5x40mm
008123520202505.5mm Pedicle Screw Assembly Ø4.5x35mm
008123520202435.5mm Pedicle Screw Assembly Ø4.5x30mm
00812352020236Curved Rod Ø5.5 x 90 mm
00812352020229Curved Rod Ø5.5 x 80 mm
00812352020212Curved Rod Ø5.5 x 70 mm
00812352020205Curved Rod Ø5.5 x 60 mm
00812352020199Curved Rod Ø5.5 x 50 mm
00812352020182Curved Rod Ø5.5 x 45 mm
00812352020175Curved Rod Ø5.5 x 40 mm
00812352020168Cross Connector, Variable, 58-80mm
00812352020151Cross Connector, Variable, 48-60mm
00812352020144Cross Connector, Variable, 43-50mm
00812352020137Cross Connector, Variable, 40-45mm
00812352020120Cross Connector, Fixed 40mm
00812352020113Cross Connector, Fixed 37mm
00812352020106Cross Connector, Fixed 34mm
00812352020090Cross Connector, Fixed 31mm
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