PECA®2.0 PS060030

GUDID 03700879516233

Bunion implant Ø4 lg30

NOVASTEP

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 03700879516233
• NIH Device Record Key: b3d59896-3274-4558-bf04-ebe685a7bd41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PECA®2.0
• Version Model Number: PS060030
• Catalog Number: PS060030
• Company DUNS: 264255288
• Company Name: NOVASTEP
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 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-intfa@enovis.com
• Phone: +33299338650
• Email: contact-intfa@enovis.com
• Phone: +33299338650
• Email: contact-intfa@enovis.com
• Phone: +33299338650
• Email: contact-intfa@enovis.com
• Phone: +33299338650
• Email: contact-intfa@enovis.com
• Phone: +33299338650
• Email: contact-intfa@enovis.com
• Phone: +33299338650
• Email: contact-intfa@enovis.com
• Phone: +33299338650
• Email: contact-intfa@enovis.com
• Phone: +33299338650
• Email: contact-intfa@enovis.com
• Phone: +33299338650
• Email: contact-intfa@enovis.com
• Phone: +33299338650
• Email: contact-intfa@enovis.com
• Phone: +33299338650
• Email: contact-intfa@enovis.com
• Phone: +33299338650
• Email: contact-intfa@enovis.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700879516233 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-25
• Device Publish Date: 2025-06-17

Devices Manufactured by NOVASTEP

• 03700879518039 - NA: 2025-09-30 Threaded shouldered pin Ø2.5 lg 72
• 03700879518046 - NA: 2025-09-30 Threaded shouldered pin Ø2.5 lg 72 - sterile
• 03700879518138 - NA: 2025-09-30 Cutting guide frame
• 03700879518145 - NA: 2025-09-30 Calca slide centering window
• 03700879518169 - NA: 2025-09-30 Calca slide cutting window
• 03700879518190 - NA: 2025-09-30 Translation tool
• 03700879518206 - NA: 2025-09-30 Threaded shouldered pin Ø3.5 lg 85
• 03700879518213 - NA: 2025-09-30 Threaded shouldered pin Ø3.5 lg 85 - sterile