Identity
- Trade Name
- SpheRx FDA UDI
- Generic Name
- Cannulated surgical drill bit, reusable FDA UDI
- Device Name
- SpheRx II Driver, Detachable Quick Conn FDA UDI
- Model / Reference
- 7100136 FDA UDI
- Description
- SpheRx II Driver, Detachable Quick Conn FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887517419583 FDA UDI
- 510(k) Number
- K112709 FDA UDI
- FDA Product Code
- ETN FDA UDI
- GMDN Term
- Cannulated surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Cannulated surgical drill bit, reusable
SpheRx by Nuvasive, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cannulated surgical drill bit, reusable.
- Thunderbolt — RESPONSIVE ORTHOPEDICS LLC · Class I
- 4.0 x 125mm Drill Bit Cann AO — OsteoCentric Technologies,Inc · Class II
- GIRO GROWTH MODULATION SYSTEM — Orthopediatrics Canada ULC · Class I
- EBA2 — Citieffe · Class II
- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
- DynaNail — Medshape, Inc. · Class I
- BIXCUT — Stryker Corp. · Class I
- FREE GLIDING SCFE SCREW SYSTEM — Orthopediatrics Canada ULC · Class I
Cleared under the same submission
K112709 also covers:
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 |
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Manufacturer
- Manufacturer
- Nuvasive, Inc.
Sources (1)
- FDA UDI d57cb430-1e23-4934-8d9b-9cc34b52b6b1 35 fields · synced May 31, 2026