Identity
- Trade Name
- Nextra PEEK Hammertoe Correction System FDA UDI
- Generic Name
- Surgical screwdriver, single-use FDA UDI
- Device Name
- PEEK Hammertoe Sterile Angled Driver FDA UDI
- Model / Reference
- PHANGD FDA UDI
- Description
- PEEK Hammertoe Sterile Angled Driver FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817701029212 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Surgical screwdriver, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical screwdriver, single-use
Nextra PEEK Hammertoe Correction System by Medartis Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical screwdriver, single-use.
- MS Removal Tool — OSSTEM IMPLANT Co., Ltd. · Class I
- HEX DRIVER 3.0 3.5 — BIOPRO, INC. · Class I
- Remover Screw — OSSTEM IMPLANT Co., Ltd. · Class I
- Orthodontic Screw Removal Tool — OSSTEM IMPLANT Co., Ltd. · Class I
- HammerTech — FUSION ORTHOPEDICS, LLC · Class I
- Remover Screw — OSSTEM IMPLANT Co., Ltd. · Class I
- CrossRoads Screw System — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
- SR Tip, Φ1.0mm, L 26mm — BIO CONCEPT Co., Ltd. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medartis Inc.
Sources (1)
- FDA UDI 837c260a-3e0e-4d0d-ad09-e7db52949fa4 33 fields · synced Jun 8, 2026