NEXIS PS050146

GUDID 03700879513089

PECA compressive screw Ø 4 length 46

NOVASTEP

Bone-nailing compression screw

• Primary Device ID: 03700879513089
• NIH Device Record Key: e53a572a-e53a-45eb-8052-a9e4cdb3aea5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEXIS
• Version Model Number: PS050146
• Catalog Number: PS050146
• Company DUNS: 264255288
• Company Name: NOVASTEP
• Device Count: 1
• DM Exempt: true
• 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: false
• Expiration Date: true
• 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: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com
• Phone: +33299338650
• Email: contact@novastep-ortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700879513089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143229

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-04
• Device Publish Date: 2020-06-16

On-Brand Devices [NEXIS]

• 03700879511337: Nexis Exact T10 PECA screwdriver non cannulated tip
• 03700879511320: Nexis Exact T10 PECA screwdriver cannulated tip
• 03700879511023: Nexis Exact T10 PECA screwdriver cannulated tip
• 03700879510873: Nexis PECA Ø3.2 canulated drill bit
• 03700879510866: Nexis PECA Ø2 canulated drill bit
• 03700879510859: Nexis Exact T10 PECA screwdriver cannulated tip
• 03700879510842: Nexis Exact T8 PECA screwdriver cannulated tip
• 03700879509563: Fraise vis headed Ø2,9
• 03700879509501: Fraise vis headed Ø2,3
• 03700879509044: Foret Nexis canulé Ø1,95 FT
• 03700879508283: Nexis T25 solid screwdriver tip
• 03700879508276: Nexis T20 solid screwdriver tip
• 03700879507545: Nexis Ø4,8 canulated drill bit
• 03700879507538: Nexis Ø3.2 canulated drill bit
• 03700879507521: Nexis Ø6 counterboring
• 03700879507514: Nexis Ø4,9 counterboring
• 03700879507491: Nexis T20 canulated screwdriver tip
• 03700879501147: Nexis Ø2,7 canulated drill bit
• 03700879501130: Nexis Ø3,7 counterboring
• 03700879500997: Nexis T10 AO screwdriver tip
• 03700879500676: Nexis Ø1,75 solid drill-bit
• 03700879500669: Nexis Ø1,75 canulated drill-bit
• 03700879500652: Nexis Ø2,75 counterboring
• 03700879500577: Nexis snap-off AO screwdriver Tip
• 03700879500560: Nexis T8 AO screwdriver Tip
• 03700879500553: Nexis T7 AO screwdriver Tip
• 03700879511009: Reduction device double tip
• 03700879509839: Nexis PECA Ruler length 150
• 03700879509471: Percutaneous rasps
• 03700879509037: Nexis Ø2,9 FT Ruler
• 03700879507675: Nexis Ø5-Ø7 graduated ruler
• 03700879505824: Perioestal elevator double tip
• 03700879503509: Nexis Graduated Ruler US length 100
• 03700879501956: Nexis Ruler length 100
• 03700879500584: Depth gauge
• 03700879500546: Nexis Ruler length 80
• 03700879512372: NEXIS Screw PECA Ø4 length 60
• 03700879512365: NEXIS Screw PECA Ø4 length 58
• 03700879512358: NEXIS Screw PECA Ø4 length 56
• 03700879512211: Nexis T8 screwdriver non cannulated
• 03700879512150: Nexis Exact T8 PECA screwdriver non cannulated
• 03700879510262: NEXIS Screw PECA Ø3 length 48
• 03700879510248: NEXIS Screw PECA Ø3 length 46
• 03700879510224: NEXIS Screw PECA Ø3 length 44
• 03700879510200: NEXIS Screw PECA Ø3 length 42
• 03700879511313: Nexis 5.0/7.0 tissue protector
• 03700879511184: Nexis 7.0 k-wire sleeve
• 03700879511177: Nexis 5.0 k-wire sleeve
• 03700879511160: Nexis 5.0/7.0 targeting guide arm
• 03700879511146: Nexis 7.0 parallel wire guide