FDA.reportPublic FDA data

MAXFRAME

Primary DI
10886982308641
Brand
MAXFRAME
Company
Synthes GmbH
Model
03.312.002
Catalog number
03312002
Device description
MAXFRAME(TM) 2.0 SOFTWARE
Published
2021-08-19
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
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
OSNSoftware for diagnosis/treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2
OSNSoftware For Diagnosis/TreatmentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211313000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211313000MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC2021-05-25KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07612334226563Direct MarkingGS10
10886982308641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612334226563076123342265637612334226563
1088698230864110886982308641

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation frame calculation softwareA stand-alone software application designed provide algorithms to assist a physician/surgeon in performing calculations to help create a schedule for the regular adjustment of an external orthopaedic fixation frame (framework) to help facilitate optimum bone growth for fracture healing. This software performs the necessary mathematical calculations and may provide a visual example of the skeletal deformities. It is intended to be installed on an off-the-shelf computer/smart device as an aid to the clinical judgement of a physician/surgeon in a clinic or hospital environment.

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982228185NA456.456S456456S2015-09-14
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14
10705034762852ACIS08.843.805088438052015-09-14
10705034762876ACIS08.843.806088438062015-09-14
10705034762890ACIS08.843.807088438072015-09-14

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