FDA.reportPublic FDA data

Orbitum X Staple

Primary DI
B565FO100124140
Brand
Orbitum X Staple
Company
CPM Medical Consultants, LLC
Model
FO-1001-2414
Catalog number
FO-1001-2414
Device description
24mm VI Hourglass Staple
Published
2023-11-10
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
JDRStaple, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173693000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173693000Orbitum Bone Staple Implant, X and VIOrthovestments, LLC2018-02-23JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B565FO100124140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone staple, non-adjustableA non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
972-331-5860xx@xx.xx

Regulatory Flags#

DUNS number
017138000
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B565OS328028L1Fuse ULTRA FOOT PLATING SYSTEMOS328028LOS328028L2026-04-17
B565M32205016L1STERIZO Total Knee SystemM-3220-5016LM-3220-5016L2026-02-26
B565M32205016S1STERIZO Total Knee SystemM-3220-5016SM-3220-5016S2026-02-26
B565OS20160960Fuse ULTRA FOOT PLATING SYSTEMOS2016096OS20160962025-05-29
B565OS4225081Fuse ULTRA FOOT PLATING SYSTEMOS422508OS4225082025-08-01
B565OS4225101Fuse ULTRA FOOT PLATING SYSTEMOS422510OS4225102025-08-01
B565OS4225121Fuse ULTRA FOOT PLATING SYSTEMOS422512OS4225122025-08-01
B565OS4225141Fuse ULTRA FOOT PLATING SYSTEMOS422514OS4225142025-08-01
B565OS4225161Fuse ULTRA FOOT PLATING SYSTEMOS422516OS4225162025-08-01
B565OS4225181Fuse ULTRA FOOT PLATING SYSTEMOS422518OS4225182025-08-01
B565OS4225201Fuse ULTRA FOOT PLATING SYSTEMOS422520OS4225202025-08-01
B565OS4225221Fuse ULTRA FOOT PLATING SYSTEMOS422522OS4225222025-08-01
B565OS4225241Fuse ULTRA FOOT PLATING SYSTEMOS422524OS4225242025-08-01
B565OS4225261Fuse ULTRA FOOT PLATING SYSTEMOS422526OS4225262025-08-01
B565OS4225281Fuse ULTRA FOOT PLATING SYSTEMOS422528OS4225282025-08-01
B565OS4225301Fuse ULTRA FOOT PLATING SYSTEMOS422530OS4225302025-08-01
B565OS4226081Fuse ULTRA FOOT PLATING SYSTEMOS422608OS4226082025-08-01
B565OS4226101Fuse ULTRA FOOT PLATING SYSTEMOS422610OS4226102025-08-01
B565OS4226121Fuse ULTRA FOOT PLATING SYSTEMOS422612OS4226122025-08-01
B565OS4226141Fuse ULTRA FOOT PLATING SYSTEMOS422614OS4226142025-08-01

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