Response Spine 5.5/6.0 System

FDA UDI

Class II (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name: Response Spine 5.5/6.0 System FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: 5.5/6.0 Uniaxial Reduction Pedicle Screws - Ø5.5mm, 55mm Length FDA UDI
Model / Reference: 00-1300-8555 FDA UDI
Description: 5.5/6.0 Uniaxial Reduction Pedicle Screws - Ø5.5mm, 55mm Length FDA UDI

Identifiers

Catalog Number: 00-1300-8555 FDA UDI
Primary DI / UDI-DI: 00841132130896 FDA UDI
FDA Product Code: MNH FDA UDI
KWP FDA UDI
OSH FDA UDI
NKB FDA UDI
MNI FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
888.3050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Spinal bone screw, non-bioabsorbable

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

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Also classified as Spinal bone screw, non-bioabsorbable.

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Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II

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 3f779d7a-3c4e-438e-8a03-e21e4388545e 35 fields · synced Jun 8, 2026