AIRLOCK SP013518

GUDID 03700879502625

Airlock Locking screw Ø3,5 length 18

NOVASTEP

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 03700879502625
• NIH Device Record Key: 48201766-29c3-4fcc-a16b-94ca48affab2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIRLOCK
• Version Model Number: SP013518
• Catalog Number: SP013518
• Company DUNS: 264255288
• Company Name: NOVASTEP
• 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: 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	03700879502625 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143523

FDA Product Code

• HRS: Plate, 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: 4
• Public Version Date: 2023-09-04
• Device Publish Date: 2015-10-16

On-Brand Devices [AIRLOCK]

• 03700879511252: Airlock MTP Plate long trial implant right
• 03700879511245: Airlock MTP Plate long trial implant left
• 03700879510927: Airlock Lisfranc plate trial T long
• 03700879510910: Airlock Lisfranc plate trial T short
• 03700879510903: Airlock Lisfranc plate trial H size L
• 03700879510897: Airlock Lisfranc plate trial H size M
• 03700879510880: Airlock Lisfranc plate trial H size S
• 03700879507859: Airlock Utility plate 7 holes trial Implant
• 03700879507842: Airlock Utility plate 6 holes trial Implant
• 03700879507835: Airlock Utility plate 5 holes trial Implant
• 03700879507828: Airlock Utility plate 4 holes trial Implant
• 03700879507811: Airlock Utility plate 3 holes trial Implant
• 03700879507804: Airlock Utility plate 2 holes trial Implant
• 03700879507767: Airlock Lapidus plate step 1 trial Implant
• 03700879507750: Implant d'essai plaque Airlock Lapidus step 4
• 03700879507743: Airlock Lapidus plate step 3 trial Implant
• 03700879507736: Airlock Lapidus plate step 2 trial Implant
• 03700879507729: Airlock Lapidus plate step 0 trial Implant
• 03700879506388: Airlock MTP Plate short trial implant Right
• 03700879506371: Airlock MTP Plate short trial implant Left
• 03700879503288: Airlock MT plate open wedge 5 trial implant right
• 03700879503271: Airlock MT plate open wedge 4 trial implant right
• 03700879503264: Airlock MT plate open wedge 3 trial implant right
• 03700879503257: Airlock MT plate closing wedge trial implant right
• 03700879503240: Airlock MT plate open wedge 5 trial implant left
• 03700879503233: Airlock MT plate open wedge 4 trial implant left
• 03700879503226: Airlock MT plate open wedge 3 trial implant left
• 03700879503219: Airlock MT plate closing wedge trial implant left
• 03700879502458: Airlock plate holder
• 03700879501987: Airlock compressive drill-guide
• 03700879501901: Airlock MTP Plate trial implant Right
• 03700879501895: Airlock MTP Plate trial implant Left
• 03700879501871: Airlock Drill-guide holder
• 03700879501864: Airlock screw measurer
• 03700879501093: Airlock locking drill guide Ø2,5
• 03700879501086: Airlock locking drill guide Ø2
• 03700879501079: Airlock polyaxial drill-guide
• 03700879500980: Airlock T8 AO screwdriver Tip
• 03700879510996: AIRLOCK Single-Use MTP Reamer 22mm
• 03700879510989: AIRLOCK Single-Use MTP Reamer 20mm
• 03700879510972: AIRLOCK Single-Use MTP Reamer 18mm
• 03700879509792: Single Use Instrumentation Kit - Benders
• 03700879509754: E-Wedge sizer 12
• 03700879509747: E-Wedge sizer 10
• 03700879509730: E-Wedge sizer 8
• 03700879509723: E-Wedge sizer 6
• 03700879509716: C-Wedge sizer 8
• 03700879509709: C-Wedge sizer 7
• 03700879509693: C-Wedge sizer 6
• 03700879509686: C-Wedge sizer 5