FDA.reportPublic FDA data

OIC Lumbar Interbody Cages

Primary DI
M696375000
Brand
OIC Lumbar Interbody Cages
Company
ORTHOPAEDIC IMPLANT COMPANY, THE
Model
375-00
Device description
LUMBAR PADDLE 6MM DISTRACTOR
Published
2017-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082260000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082260000INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGESCalvary Spine, LLC2008-10-17MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M696375000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical distractor, internalA hand-held manual surgical instrument designed to invasively distract (force apart) two bone surfaces to enable a surgical procedure. It typically aids in fracture reduction by helping to temporarily stabilize bones prior to definitive surgical fixation. It typically consists of a central threaded spindle, a static endpiece and a sliding carriage that can be adjusted using spindle nuts to/from the endpiece to widen or shorten the gap; it facilitates the attachment of orthopaedic bone pins (Schanz screws) screwed into the bones to be distracted. It is typically used for multiple injuries when it is advantageous to perform procedures on a standard operating table. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
775 636 8281Info@OrthoImplantCompany.com

Regulatory Flags#

DUNS number
070061160
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10811998032150OIC Cannulated Screw System01-SHS102018-07-31
10811998036301OIC Intramedullary Nail System01-IM302018-07-31
10811998036325OIC Intramedullary Nail System01-IM322018-07-31
10811998036349OIC Intramedullary Nail System01-IM342018-07-31
10811998036387OIC Intramedullary Nail System01-IM402018-07-31
10811998036394OIC Intramedullary Nail System01-IM412018-07-31
10811998036561OIC Intramedullary Nail System01-IM582018-08-07
10811998038022OIC Intramedullary Nail System01-IMSE032018-08-07
10811998038039OIC Intramedullary Nail System01-IMSE042018-08-07
M69601IM300OIC Intramedullary Nail System01-IM302017-02-01
M69601IM320OIC Intramedullary Nail System01-IM322017-02-01
M69601IM340OIC Intramedullary Nail System01-IM342017-02-01
M69601IM400OIC Intramedullary Nail System01-IM402017-02-01
M69601IM410OIC Intramedullary Nail System01-IM412017-02-01
M69601SHS100OIC Cannulated Screw System01-SHS102017-02-01
10811998039555OIC Variable Angle Small Fragment Locking Plate System01-SF272023-09-06
10811998033478OIC Variable Angle Small Fragment Locking Plate System01-SF112018-07-31
10811998033485OIC Variable Angle Small Fragment Locking Plate System01-SF122018-07-31
M69601SF110OIC Variable Angle Small Fragment Locking Plate System01-SF112017-02-01
M69601SF120OIC Variable Angle Small Fragment Locking Plate System01-SF122017-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B707125355730600DUALX DUAL PORTAL DISPOSABLE KIT-60MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730700DUALX DUAL PORTAL DISPOSABLE KIT-70MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730800DUALX DUAL PORTAL DISPOSABLE KIT-80MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730900DUALX DUAL PORTAL DISPOSABLE KIT-90MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355731000DUALX DUAL PORTAL DISPOSABLE KIT-100MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355731100DUALX DUAL PORTAL DISPOSABLE KIT-110MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355731200DUALX DUAL PORTAL DISPOSABLE KIT-120MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
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