← Back to catalogue

OP Response Spine System

FDA UDI

Class II (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name
OP Response Spine System FDA UDI
Generic Name
Trans-facet-screw internal spinal fixation system, sterile FDA UDI
Device Name
Ø 5.5MM COCR ROD, 500MM FDA UDI
Model / Reference
00-1003-3001 FDA UDI
Description
Ø 5.5MM COCR ROD, 500MM FDA UDI

Identifiers

Catalog Number
00-1003-3001 FDA UDI
Primary DI / UDI-DI
00841132119723 FDA UDI
510(k) Number
K130655 FDA UDI
FDA Product Code
KWP FDA UDI
OSH FDA UDI
GMDN Term
Trans-facet-screw internal spinal fixation system, sterile FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Category: Trans-facet-screw internal spinal fixation system, sterile

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

Similar devices

Also classified as Trans-facet-screw internal spinal fixation system, sterile.

Cleared under the same submission

K130655 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Orthopediatrics Corp.

Sources (1)

  • FDA UDI e32f2e2d-c277-4d18-a289-684315a4c112 36 fields · synced May 30, 2026