SD420507

GUDID H980SD42050705

PSI SD420.507 TITANIUM IMPLANT

Synthes GmbH

Custom-made cranial bone prosthesis
Primary Device IDH980SD42050705
NIH Device Record Key19ae16bc-2468-467d-aaad-f8bfaade1b27
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSD420.507
Catalog NumberSD420507
Company DUNS486711679
Company NameSynthes GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110887587075266 [Primary]
HIBCCH980SD42050705 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXNPLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H980SD42050705]

Moist Heat or Steam Sterilization


[H980SD42050705]

Moist Heat or Steam Sterilization


[H980SD42050705]

Moist Heat or Steam Sterilization


[H980SD42050705]

Moist Heat or Steam Sterilization


[H980SD42050705]

Moist Heat or Steam Sterilization


[H980SD42050705]

Moist Heat or Steam Sterilization


[H980SD42050705]

Moist Heat or Steam Sterilization


[H980SD42050705]

Moist Heat or Steam Sterilization


[H980SD42050705]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-25
Device Publish Date2022-07-15

Devices Manufactured by Synthes GmbH

10886982350039 - NA2025-08-15 CRE DRILL GUIDE 15MM
10886982350046 - NA2025-08-15 CRE DRILL GUIDE 18MM
10886982350053 - NA2025-08-15 CRE DRILL GUIDE 20MM
10886982350060 - NA2025-08-15 CRE DRILL GUIDE 25MM
10886982350077 - NA2025-08-15 7.0MM CAN TAP LARGE QUICK COUPLING
07612334226747 - NA2025-07-31 LID 2/3 SIZE STAINLESS STEEL
07612334227980 - NA2025-07-31 TRAY FOR OPERACE, 1 FROM 2
07612334228352 - NA2025-07-31 TRAY FOR OPERACE, 2 FROM 2

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.