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Response Spine System

FDA UDI

Class II (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name
Response Spine System FDA UDI
Generic Name
Bone-screw internal spinal fixation system connector FDA UDI
Device Name
5.5/6.0 FIXED CROSS CONNECTOR, 20MM FDA UDI
Model / Reference
00-1300-5020 FDA UDI
Description
5.5/6.0 FIXED CROSS CONNECTOR, 20MM FDA UDI

Identifiers

Catalog Number
00-1300-5020 FDA UDI
Primary DI / UDI-DI
00841132103401 FDA UDI
FDA Product Code
NKB FDA UDI
GMDN Term
Bone-screw internal spinal fixation system connector 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

Yes

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

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
MRI Safety
MR Conditional FDA UDI

Category: Bone-screw internal spinal fixation system connector

Response Spine System by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system connector.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthopediatrics Corp.

Sources (1)

  • FDA UDI e664b850-fc3c-4104-a716-8be8b5aa8711 35 fields · synced Jun 8, 2026