FDA.reportPublic FDA data

Royal Oak Pedicle Screw System

Primary DI
00812352021318
Brand
Royal Oak Pedicle Screw System
Company
Royal Oak Medical Devices LLC
Model
4302081
Device description
Royal Oak Pedicle Screw Instrument Set Case 2
Published
2015-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110046000ATHENA PEDICLE SCREW SYSTEMRoyal Oak Medical Devices2011-12-07NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812352021318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812352021318008123520213188123520213180812352021318

GMDN Terms#

Term, Definition table
TermDefinition
External spinal fixation systemAn assembly of devices designed to stabilize adjacent segments (i.e., vertebrae) of the spine. It typically consists of an external plastic and/or metallic fixator and other external and/or implantable components, such as plates, rods, pins, and bone screws; it may also include some instruments appropriate for attaching the implants (e.g., screw drivers, wrenches, drills). The system is intended for temporary immobilization of segments of the spine in patients with fractures of the thoracic and/or lumbar spine and also for some patients suffering of segmental instability or chronic back pain. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
248-853-1450customerservice@royaloakmed.com

Regulatory Flags#

DUNS number
017825896
Device count
1
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812352020311Royal Oak Pedicle Screw SystemPS5.5-5.5-452014-09-20
00812352020014Royal Oak Pedicle Screw SystemPS5.5-5.5-302014-09-20
00812352020113Royal Oak Pedicle Screw SystemCCF5.5-372014-09-20
00812352020137Royal Oak Pedicle Screw SystemCCV5.5-40-452014-09-20
00812352020144Royal Oak Pedicle Screw SystemCCV5.5-43-502014-09-20
00812352020151Royal Oak Pedicle Screw SystemCCV5.5-48-602014-09-20
00812352020168Royal Oak Pedicle Screw SystemCCV5.5-58-802014-09-20
00812352020175Royal Oak Pedicle Screw SystemCR5.5-402014-09-20
00812352020199Royal Oak Pedicle Screw SystemCR5.5-502014-09-20
00812352020205Royal Oak Pedicle Screw SystemCR5.5-602014-09-20
00812352020212Royal Oak Pedicle Screw SystemCR5.5-702014-09-20
00812352020229Royal Oak Pedicle Screw SystemCR5.5-802014-09-20
00812352020236Royal Oak Pedicle Screw SystemCR5.5-902014-09-20
00812352020243Royal Oak Pedicle Screw SystemPS5.5-4.5-302014-09-20
00812352020250Royal Oak Pedicle Screw SystemPS5.5-4.5-352014-09-20
00812352020267Royal Oak Pedicle Screw SystemPS5.5-4.5-402014-09-20
00812352020274Royal Oak Pedicle Screw SystemPS5.5-4.5-452014-09-20
00812352020298Royal Oak Pedicle Screw SystemPS5.5-5.5-352014-09-20
00812352020304Royal Oak Pedicle Screw SystemPS5.5-5.5-402014-09-20
00812352020328Royal Oak Pedicle Screw SystemPS5.5-5.5-502014-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493423166RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423173RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423197RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423234RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423241RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423258RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423265RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423272RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423289RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423296RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423302RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423319RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423326RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423333RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423340RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423357RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423364RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423371RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423388RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423395RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423401RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423418RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423425RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423432RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423449RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423456RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08