Identity
- Trade Name
- Response Navigation FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- 5.5/6.0 Cannulated Pedicle Screw Driver Navigation FDA UDI
- Model / Reference
- 01-1800-6042 FDA UDI
- Description
- 5.5/6.0 Cannulated Pedicle Screw Driver Navigation FDA UDI
Identifiers
- Catalog Number
- 01-1800-6042 FDA UDI
- Primary DI / UDI-DI
- 00840194462778 FDA UDI
- 510(k) Number
- K203573 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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: Surgical screwdriver, reusable
Response Navigation by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical screwdriver, reusable.
- Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class I
- LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
- PERLA ® TL — Spineart · Class II
- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
Cleared under the same submission
K203573 also covers:
- Naviagtion Instrumentation — ORTHOPEDIATRICS CORP.
- Naviagtion Instrumentation — ORTHOPEDIATRICS CORP.
- Naviagtion Instrumentation — ORTHOPEDIATRICS CORP.
- Naviagtion Instrumentation — ORTHOPEDIATRICS CORP.
- Naviagtion Instrumentation — ORTHOPEDIATRICS CORP.
- Response Navigation — ORTHOPEDIATRICS CORP.
- Response Navigation — ORTHOPEDIATRICS CORP.
- Response Navigation — ORTHOPEDIATRICS CORP.
- Response Navigation — ORTHOPEDIATRICS CORP.
- Response Navigation — ORTHOPEDIATRICS CORP.
- Response Navigation — ORTHOPEDIATRICS CORP.
- Response Navigation — ORTHOPEDIATRICS CORP.
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
- Orthopediatrics Corp.
Sources (1)
- FDA UDI f8025ab3-04ed-489a-8700-b1ebc47429bb 35 fields · synced May 31, 2026