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

• 03700879515342 - PECA® 2.0: 2025-06-25 Bunion implant Ø3 lg16
• 03700879515359 - PECA® 2.0: 2025-06-25 Bunion implant Ø3 lg18
• 03700879515366 - PECA® 2.0: 2025-06-25 Bunion implant Ø3 lg20
• 03700879515373 - PECA® 2.0: 2025-06-25 Bunion implant Ø3 lg22
• 03700879515380 - PECA® 2.0: 2025-06-25 Bunion implant Ø3 lg24
• 03700879515397 - PECA® 2.0: 2025-06-25 Bunion implant Ø3 lg26
• 03700879516196 - PECA® 2.0: 2025-06-25 Removal AO T15 screwdriver tip
• 03700879516202 - PECA® 2.0: 2025-06-25 Exact2-T®15 AO screwdriver tip