SACRONAIL PBZ0001-4-A

GUDID 04047844122013

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 ID: 04047844122013
• NIH Device Record Key: a2a5c66f-73e8-4fd4-b839-a3e227446f3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SACRONAIL
• Version Model Number: Instrument guide
• Catalog Number: PBZ0001-4-A
• Company DUNS: 344203948
• Company Name: SIGNUS Medizintechnik GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04047844122013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212755

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04047844122013]

Moist Heat or Steam Sterilization

[04047844122013]

Moist Heat or Steam Sterilization

[04047844122013]

Moist Heat or Steam Sterilization

[04047844122013]

Moist Heat or Steam Sterilization

[04047844122013]

Moist Heat or Steam Sterilization

[04047844122013]

Moist Heat or Steam Sterilization

[04047844122013]

Moist Heat or Steam Sterilization

[04047844122013]

Moist Heat or Steam Sterilization

[04047844122013]

Moist Heat or Steam Sterilization

[04047844122013]

Moist Heat or Steam Sterilization

[04047844122013]

Moist Heat or Steam Sterilization

[04047844122013]

Moist Heat or Steam Sterilization

[04047844122013]

Moist Heat or Steam Sterilization

[04047844122013]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-13
• Device Publish Date: 2024-06-05

On-Brand Devices [SACRONAIL]

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