SACRONAIL PBZ0001-12-A

GUDID 04047844121986

The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractures and sacral fractures through its intraosseous location and its direct, bi-iliac symmetric anchorage. The implant consists of a nail of various lengths from135mm to 194mm with a constant diameter of 8mm and 2 locking screws in different lengths. This variation ensures adaptation to the respective anatomy of the patient. The intersections of the screw axes to the implant axis have a distance of 15mm to the respective end face of the nail. This ensures a solid support on the lateral cortex of the Ilia. The angle of the screw axes to the implant axis corresponds to the anatomical conditions and is 70°. The locking screw ensures a stable connection of the components. The tips of the locking screws are rounded to facilitate insertion into the nail while the dorsal ends of locking screws are a hexagon. The caps serve to close the instrument connection of the nail. The implants are made from the Titanium alloy (Ti6Al4V) according to ASTM F 136 / ISO 5832-3, with a Type II anodization according to AMS 2488. There are Instruments which are specific to the implantation of the SACRONAIL device. These include, but are not limited to, the Guide Frame, the Guide Bracket, the Fixation Bracket, various Instrument Guides, various dilators and drills, screwdrivers as well as the specific tools for revision of the device.

SIGNUS Medizintechnik GmbH

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID04047844121986
NIH Device Record Keyae041519-464d-4596-9fa3-8edb5406fe95
Commercial Distribution StatusIn Commercial Distribution
Brand NameSACRONAIL
Version Model NumberAnvil
Catalog NumberPBZ0001-12-A
Company DUNS344203948
Company NameSIGNUS Medizintechnik 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104047844121986 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04047844121986]

Moist Heat or Steam Sterilization

[04047844121986]

Moist Heat or Steam Sterilization

[04047844121986]

Moist Heat or Steam Sterilization

[04047844121986]

Moist Heat or Steam Sterilization

[04047844121986]

Moist Heat or Steam Sterilization

[04047844121986]

Moist Heat or Steam Sterilization

[04047844121986]

Moist Heat or Steam Sterilization

[04047844121986]

Moist Heat or Steam Sterilization

[04047844121986]

Moist Heat or Steam Sterilization

[04047844121986]

Moist Heat or Steam Sterilization

[04047844121986]

Moist Heat or Steam Sterilization

[04047844121986]

Moist Heat or Steam Sterilization

[04047844121986]

Moist Heat or Steam Sterilization

[04047844121986]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-13
Device Publish Date2024-06-05

On-Brand Devices [SACRONAIL]

04047844039618DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844062920DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039922DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039915DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039908DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039892DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039885DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039878DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039861DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039854DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039847DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039830DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039823DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039816DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039809DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039793DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039786DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039779DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039762DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039755DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039748DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039731DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039724DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039717DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039700DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039694DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039687DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039670DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039663DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039656DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039649DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039632DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844039625DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractu
04047844112021An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical p
04047844112014An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical p
04047844112007An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical p
04047844111994The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractures and sac
04047844111987The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractures and sac
04047844101230An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical p
04047844101223An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical p
04047844101216The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractures and sac
04047844101209The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractures and sac
04047844081266An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical p
04047844081259An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical p
04047844081242An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical p
04047844066584An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical p
04047844064788An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical p
04047844064771An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical p
04047844064764An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical p
04047844057834An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical p
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