PECA® 2.0 PS070016

GUDID 03700879515342

Bunion implant Ø3 lg16

NOVASTEP

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 03700879515342
• NIH Device Record Key: 38204a5c-608d-4343-98a5-8d7ca6034c88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PECA® 2.0
• Version Model Number: PS070016
• Catalog Number: PS070016
• 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	03700879515342 [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

On-Brand Devices [PECA® 2.0]

• 03700879517766: Ø3 - K-wire sleeve
• 03700879517759: Ø4 - K-wire sleeve
• 03700879517742: Targeting guide adaptator
• 03700879517735: Parallel guide Ø4-Ø3
• 03700879517728: Parallel guide Ø4-Ø4
• 03700879517711: Tissue protector
• 03700879517704: Single-use drill bit Ø2
• 03700879517698: Drill bit Ø2
• 03700879517681: AO Drill bit Ø2
• 03700879517674: Removal AO T10 screwdriver tip
• 03700879517667: Exact2-T10 AO screwdriver tip
• 03700879517650: Countersink Ø3.7
• 03700879517643: Single-use drill bit Ø3.2
• 03700879517636: Drill bit Ø3.2
• 03700879517629: AO Drill bit Ø3.2
• 03700879517599: Bunion implant Ø3 lg48
• 03700879517582: Bunion implant Ø3 lg46
• 03700879517575: Bunion implant Ø3 lg44
• 03700879517568: Bunion implant Ø3 lg42
• 03700879517551: Bunion implant Ø3 lg40
• 03700879517544: Bunion implant Ø3 lg38
• 03700879517537: Bunion implant Ø3 lg36
• 03700879517520: Bunion implant Ø3 lg34
• 03700879517513: Bunion implant Ø3 lg32
• 03700879517506: Bunion implant Ø3 lg30
• 03700879517490: Bunion implant Ø3 lg28
• 03700879516387: Bunion implant Ø4 lg60
• 03700879516370: Bunion implant Ø4 lg58
• 03700879516363: Bunion implant Ø4 lg56
• 03700879516356: Bunion implant Ø4 lg54
• 03700879516349: Bunion implant Ø4 lg52
• 03700879516332: Bunion implant Ø4 lg50
• 03700879516325: Bunion implant Ø4 lg48
• 03700879516318: Bunion implant Ø4 lg46
• 03700879516301: Bunion implant Ø4 lg44
• 03700879516295: Bunion implant Ø4 lg42
• 03700879516288: Bunion implant Ø4 lg40
• 03700879516271: Bunion implant Ø4 lg38
• 03700879516264: Bunion implant Ø4 lg36
• 03700879516257: Bunion implant Ø4 lg34
• 03700879516240: Bunion implant Ø4 lg32
• 03700879516226: Bunion implant Ø4 lg28
• 03700879516219: Bunion implant Ø4 lg26
• 03700879516202: Exact2-T®15 AO screwdriver tip
• 03700879516196: Removal AO T15 screwdriver tip
• 03700879515397: Bunion implant Ø3 lg26
• 03700879515380: Bunion implant Ø3 lg24
• 03700879515373: Bunion implant Ø3 lg22
• 03700879515366: Bunion implant Ø3 lg20
• 03700879515359: Bunion implant Ø3 lg18