FDA.reportPublic FDA data

Royal Oak IBFD Implant System

Primary DI
00812352021288
Brand
Royal Oak IBFD Implant System
Company
ROMD, LLC
Model
4501081
Device description
Royal Oak IBFD Instrument Set Case 1
Published
2015-09-22
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
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812352021288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812352021288008123520212888123520212880812352021288

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
248-951-1550customerservice@royaloakmed.com

Regulatory Flags#

DUNS number
069728508
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840606185141LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185158LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185165LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196024VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196031VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196048VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.MAX2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
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10888857218772CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
07613153046196AVS PLStryker CorporationMAX2015-09-14
07613153046202AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMAX2015-09-14
07613153046226AVS PLStryker CorporationMAX2015-09-14
07613153046233AVS PLStryker CorporationMAX2015-09-14
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07613153046295AVS PLStryker CorporationMAX2015-09-14
07613153046301AVS PLStryker CorporationMAX2015-09-14
07613153046318AVS PLStryker CorporationMAX2015-09-14
07613153046325AVS PLStryker CorporationMAX2015-09-14
07613153046332AVS PLStryker CorporationMAX2015-09-14
07613153046349AVS PLStryker CorporationMAX2015-09-14