FDA.reportPublic FDA data

Royal Oak Pedicle Screw System

Primary DI
00812352020168
Brand
Royal Oak Pedicle Screw System
Company
ROMD, LLC
Model
CCV5.5-58-80
Device description
Cross Connector, Variable, 58-80mm
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
00812352020168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812352020168008123520201688123520201680812352020168

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system connectorAn implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

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
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
00812352020267Royal Oak Pedicle Screw SystemPS5.5-4.5-402014-09-20

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