FDA.report

Orthex External Fixation System

Primary DI
00840194480307
Company
ORTHOPEDIATRICS CORP.
Model
SB40-200-10
Catalog number
SB40-200-10
Device description
Ti Half Pin, SB, Orthex 4.0x200x10 HA
Published
2025-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
796416191
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
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00840194480307PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00840194480307PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
JDWPin, Fixation, Threaded2Orthopedic888.3040YEligible

Premarket Submissions

SubmissionSupplement
K243798000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K243798000Orthex External Fixation SystemOrthoPediatrics Corp.2025-03-07KTT

GMDN Terms

TermDefinition
External orthopaedic fixation system, single-useAn assembly of devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(574)268-6379xxx@xxx.com

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