FDA.reportPublic FDA data

Royal Oak Pedicle Screw System

Primary DI
00812352020434
Brand
Royal Oak Pedicle Screw System
Company
ROMD, LLC
Model
PS5.5-7.5-50
Device description
5.5mm Pedicle Screw Assembly Ø7.5x50mm
Published
2014-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00812352020434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812352020434008123520204348123520204340812352020434

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
248-951-1550customerservice@royaloakmed.com

Regulatory Flags#

DUNS number
069728508
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812352020007Royal Oak Pedicle Screw SystemPS5.5-40012014-09-20
00812352020014Royal Oak Pedicle Screw SystemPS5.5-5.5-302014-09-20
00812352020076Royal Oak Pedicle Screw SystemPS5.5-4001-42015-10-21
00812352020083Royal Oak Pedicle Screw SystemCCF5.5-282014-09-20
00812352020090Royal Oak Pedicle Screw SystemCCF5.5-312014-09-20
00812352020106Royal Oak Pedicle Screw SystemCCF5.5-342014-09-20
00812352020113Royal Oak Pedicle Screw SystemCCF5.5-372014-09-20
00812352020120Royal Oak Pedicle Screw SystemCCF5.5-402014-09-20
00812352020137Royal Oak Pedicle Screw SystemCCV5.5-40-452014-09-20
00812352020144Royal Oak Pedicle Screw SystemCCV5.5-43-502014-09-20
00812352020168Royal Oak Pedicle Screw SystemCCV5.5-58-802014-09-20
00812352020175Royal Oak Pedicle Screw SystemCR5.5-402014-09-20
00812352020182Royal Oak Pedicle Screw SystemCR5.5-452014-09-19
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

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