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
10840642134797Salvo® Spine SystemSpine Wave, Inc.NKB2026-07-16
M719GL2290TiLockGenesys Orthopedics Systems LLCMNH2026-07-14
M719GL2290TiLockGenesys Orthopedics Systems LLCMNI2026-07-14
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424835RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424842RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424859RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424866RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424873RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424880RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424897RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424903RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424910RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424927RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424934RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424941RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424958RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424965RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424972RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13