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Response 4.5/5.0 Spine System

FDA UDI

Class I (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name
Response 4.5/5.0 Spine System FDA UDI
Generic Name
Vertical expandable prosthetic rib system FDA UDI
Device Name
HOOK HOLDER, STRAIGHT FDA UDI
Model / Reference
01-1600-6150 FDA UDI
Description
HOOK HOLDER, STRAIGHT FDA UDI

Identifiers

Catalog Number
01-1600-6150 FDA UDI
Primary DI / UDI-DI
00841132156834 FDA UDI
FDA Product Code
HTD FDA UDI
GMDN Term
Vertical expandable prosthetic rib system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

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

Yes

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: Vertical expandable prosthetic rib system

Response 4.5/5.0 Spine System by Orthopediatrics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vertical expandable prosthetic rib system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthopediatrics Corp.

Sources (1)

  • FDA UDI 26e10d98-1bc1-4273-8b78-6f07b33fa171 35 fields · synced May 30, 2026