MAXFRAME 03312816

GUDID H679033128160

MAXFRAME(TM) STANDARD STRUT/SHORT

Synthes GmbH

External orthopaedic fixation system, reusable
Primary Device IDH679033128160
NIH Device Record Key311ee03c-6e9b-4b11-9464-db5e02c9600c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAXFRAME
Version Model Number03.312.816
Catalog Number03312816
Company DUNS486711679
Company NameSynthes GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982261076 [Primary]
HIBCCH679033128160 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679033128160]

Moist Heat or Steam Sterilization

[H679033128160]

Moist Heat or Steam Sterilization

[H679033128160]

Moist Heat or Steam Sterilization

[H679033128160]

Moist Heat or Steam Sterilization

[H679033128160]

Moist Heat or Steam Sterilization

[H679033128160]

Moist Heat or Steam Sterilization

[H679033128160]

Moist Heat or Steam Sterilization

[H679033128160]

Moist Heat or Steam Sterilization

[H679033128160]

Moist Heat or Steam Sterilization

[H679033128160]

Moist Heat or Steam Sterilization

[H679033128160]

Moist Heat or Steam Sterilization

[H679033128160]

Moist Heat or Steam Sterilization

[H679033128160]

Moist Heat or Steam Sterilization

[H679033128160]

Moist Heat or Steam Sterilization

[H679033128160]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-05-02
Device Publish Date2017-04-19

On-Brand Devices [MAXFRAME]

07612334107190MAXFRAME(TM) FOOT PL LONG 120MM/150MM/180MM/210MM
07612334107176MAXFRAME(TM) STRUT SWAP KIT CASE
07612334118554MAXFRAME(TM) SHOULDER BOLT RACK
07612334105448MAXFRAME(TM) IMPLANTS/INSTR CASE 3
07612334107213MAXFRAME(TM) IMPLANTS/ STANDARD STRUTS
07612334107206MAXFRAME(TM) IMPLANTS/ QUICK ADJUST STRUTS
07612334107152MAXFRAME(TM) 5/8 & BRIDGING PL 150MM/180MM/210MM
07612334105431MAXFRAME(TM) FULL RINGS 150MM/180MM/210MM
07612334105240MAXFRAME (TM) FOOT PL SHORT 120MM, 150MM, 180MM, 210MM
07612334107220MAXFRAME (TM) RINGS 90MM & 120MM
07612334105424MAXFRAME(TM) IMPLANTS/INSTR CASE 2
07612334105417MAXFRAME(TM) IMPLANTS/INSTR CASE 1
07612334107237WIRE TENSIONER
H679033128180MAXFRAME(TM) STANDARD STRUT/LONG
H679033128170MAXFRAME(TM) STANDARD STRUT/MEDIUM
H679033128160MAXFRAME(TM) STANDARD STRUT/SHORT
H679033128150MAXFRAME(TM) STANDARD STRUT/X-SHORT
H679033128140MAXFRAME(TM) STANDARD STRUT/XX-SHORT
H679033128130MAXFRAME(TM) QUICK ADJUST STRUT/LONG
H679033128120MAXFRAME(TM) QUICK ADJUST STRUT/MEDIUM
H679033128110MAXFRAME(TM) QUICK ADJUST STRUT/SHORT
H679033128100MAXFRAME(TM) QUICK ADJUST STRUT/X-SHORT
H679033128300MAXFRAME(TM) SHOULDER BOLT FOR 8MM RINGS
H679033128210MAXFRAME(TM) STRUT ID PLUG SET
H679033128200MAXFRAME(TM) STRUT ID BAND SET
H679033124400MAXFRAME(TM) BRIDGING PLATE FOR 5/8 RING 240MM/ALUMINUM
H679033124100MAXFRAME(TM) BRIDGING PLATE FOR 5/8 RING 210MM/ALUMINUM
H679033123800MAXFRAME(TM) BRIDGING PLATE FOR 5/8 RING 180MM/ALUMINUM
H679033123500MAXFRAME(TM) BRIDGING PLATE FOR 5/8 RING 150MM/ALUMINUM
H679033122700MAXFRAME(TM) FULL RING 270MM ALUMINUM
H679033122400MAXFRAME(TM) FULL RING 240MM ALUMINUM
H679033122100MAXFRAME(TM) FULL RING 210MM ALUMINUM
H679033121800MAXFRAME(TM) FULL RING 180MM ALUMINUM
H679033121500MAXFRAME(TM) FULL RING 150MM ALUMINUM
H679033121200MAXFRAME(TM) FULL RING 120MM ALUMINUM
H679033127400MAXFRAME(TM) 5/8 RING 240MM/ALUMINUM
H679033127100MAXFRAME(TM) 5/8 RING 210MM/ALUMINUM
H679033126800MAXFRAME(TM) 5/8 RING 180MM/ALUMINUM
H679033126500MAXFRAME(TM) 5/8 RING 150MM/ALUMINUM
H679033126200MAXFRAME(TM) 5/8 RING 120MM/ALUMINUM
H679033125900MAXFRAME(TM) 5/8 RING 90MM/ALUMINUM
H679033122010MAXFRAME(TM) FOOT PLATE SHORT 210MM/ALUMINUM
H679033121810MAXFRAME(TM) FOOT PLATE SHORT 180MM/ALUMINUM
H679033120900MAXFRAME(TM) FULL RING 90MM/ALUMINUM
H679033121610MAXFRAME(TM) FOOT PLATE SHORT 150MM/ALUMINUM
H679033121410MAXFRAME(TM) FOOT PLATE SHORT 120MM/ALUMINUM
H679033123010MAXFRAME(TM) FOOT PLATE LONG 210MM/ALUMINUM
H679033122810MAXFRAME(TM) FOOT PLATE LONG 180MM/ALUMINUM
H679033122610MAXFRAME(TM) FOOT PLATE LONG 150MM/ALUMINUM
H679033122410MAXFRAME(TM) FOOT PLATE LONG 120MM/ALUMINUM

Trademark Results [MAXFRAME]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MAXFRAME
MAXFRAME
86804597 5413295 Live/Registered
Depuy Synthes, Inc.
2015-10-30
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.