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Response 5.5, Response 5.5/6.0

FDA UDI

Class II (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name
Response 5.5, Response 5.5/6.0 FDA UDI
Generic Name
Orthopaedic rod reducer FDA UDI
Device Name
5.5/6.0 Extended Mini-Reducer FDA UDI
Model / Reference
01-1300-8700 FDA UDI
Description
5.5/6.0 Extended Mini-Reducer FDA UDI

Identifiers

Catalog Number
01-1300-8700 FDA UDI
Primary DI / UDI-DI
00840194478519 FDA UDI
FDA Product Code
NKB FDA UDI
GMDN Term
Orthopaedic rod reducer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic rod reducer

Response 5.5, Response 5.5/6.0 by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic rod reducer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthopediatrics Corp.

Sources (1)

  • FDA UDI c84e8118-97f0-4398-8a22-18fd77a5cb35 34 fields · synced May 30, 2026