FDA.reportPublic FDA data

MAXFRAME

Primary DI
07612334226563
Brand
MAXFRAME
Company
SYNTHES (U.S.A.) LP
Model
03.312.002
Catalog number
03312002
Device description
MAXFRAME(TM) 2.0 SOFTWARE
Published
2021-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSNSoftware for diagnosis/treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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 web-based calculator softwareAn application software designed to 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. The software is accessed via an Internet connection utilizing a web browser (e.g., Microsoft® Internet Explorer). This software performs the necessary mathematical calculations and may provide a visual example of the skeletal deformities. It is intended to be used as an aid to the clinical judgement of a physician/surgeon in a clinic or hospital environment.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
832637081
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982027795NA02.007.000S02007000S2015-09-14
10886982066763NA03.007.020030070202016-12-31
10886982160898NA237.043S237043S2015-09-14
10886982160904NA237.044S237044S2015-09-14
10886982160928NA237.054S237054S2015-09-14
10886982160935NA237.063S237063S2015-09-14
10886982160942NA237.064S237064S2015-09-14
10886982160959NA237.083S237083S2015-09-14
10886982160966NA237.084S237084S2015-09-14
10886982160973NA237.085S237085S2015-09-14
10886982160980NA237.086S237086S2015-09-14
10886982161000NA237.104S237104S2015-09-14
10886982161017NA237.105S237105S2015-09-14
10886982161024NA237.106S237106S2015-09-14
10886982161031NA237.123S237123S2015-09-14
10886982161048NA237.124S237124S2015-09-14
10886982161055NA237.125S237125S2015-09-14
10886982162038LCP238.7002387002015-09-14
10886982162052LCP238.7012387012015-09-14
10886982162076LCP238.7022387022015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982303608NASynthes GmbHOSN2022-02-07
10886982303615NASynthes GmbHOSN2022-02-07
10886982303639NASynthes GmbHOSN2022-02-07
10886982303653NASynthes GmbHOSN2022-02-07
10886982303738NASynthes GmbHOSN2022-02-07
10886982303769NASynthes GmbHOSN2022-02-07
10886982303813NASynthes GmbHOSN2022-02-07
10886982303837NASynthes GmbHOSN2022-02-07
10886982303844NASynthes GmbHOSN2022-02-07
10886982303899NASynthes GmbHOSN2022-02-07
10886982303974NASynthes GmbHOSN2022-02-07
10886982303981NASynthes GmbHOSN2022-02-07
10886982304070NASynthes GmbHOSN2022-02-07
10886982304094NASynthes GmbHOSN2022-02-07
10886982304100NASynthes GmbHOSN2022-02-07
10886982304124NASynthes GmbHOSN2022-02-07
10886982304131NASynthes GmbHOSN2022-02-07
10886982304148NASynthes GmbHOSN2022-02-07
10886982304209NASynthes GmbHOSN2022-02-07
10886982304216NASynthes GmbHOSN2022-02-07
10886982304223NASynthes GmbHOSN2022-02-07
10886982304322NASynthes GmbHOSN2022-02-07
10886982304346NASynthes GmbHOSN2022-02-07
10886982304353NASynthes GmbHOSN2022-02-07
10886982304414NASynthes GmbHOSN2022-02-07
10886982304483NASynthes GmbHOSN2022-02-07
10886982304506NASynthes GmbHOSN2022-02-07
10886982304568NASynthes GmbHOSN2022-02-07
10886982304575NASynthes GmbHOSN2022-02-07
10886982304582NASynthes GmbHOSN2022-02-07