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RESPONSE 5.5/6.0 Spine System

FDA UDI

Class II (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name
RESPONSE 5.5/6.0 Spine System FDA UDI
Generic Name
Trans-facet-screw internal spinal fixation system, sterile FDA UDI
Device Name
S-ROD, Ø 6.0MM COCR, 450MM, 65MM STRAIGHT FDA UDI
Model / Reference
00-1600-0066 FDA UDI
Description
S-ROD, Ø 6.0MM COCR, 450MM, 65MM STRAIGHT FDA UDI

Identifiers

Catalog Number
00-1600-0066 FDA UDI
Primary DI / UDI-DI
00841132145876 FDA UDI
510(k) Number
K150600 FDA UDI
FDA Product Code
KWP FDA UDI
OSH FDA UDI
NKB FDA UDI
MNH FDA UDI
MNI 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
Not 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

Yes

FDA UDI

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

Cleared under the same submission

K150600 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthopediatrics Corp.

Sources (1)

  • FDA UDI 6153c001-8b53-48df-866e-4a74a8c81c79 37 fields · synced May 31, 2026