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RENOIR Posterior Cervico-Thoracic Fixation System

FDA UDI

Class II (US FDA UDI)

by CTL Medical Corporation

Identity

Trade Name
RENOIR Posterior Cervico-Thoracic Fixation System FDA UDI
Generic Name
Internal spinal fixation procedure kit, reusable FDA UDI
Device Name
Probe, Curved FDA UDI
Model / Reference
012.7033 FDA UDI
Description
Probe, Curved FDA UDI

Identifiers

Catalog Number
012.7033 FDA UDI
Primary DI / UDI-DI
00841732104761 FDA UDI
510(k) Number
K121136 FDA UDI
FDA Product Code
MNI FDA UDI
KWP FDA UDI
GMDN Term
Internal spinal fixation procedure kit, reusable 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

No

FDA UDI

Single Use

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Internal spinal fixation procedure kit, reusable

RENOIR Posterior Cervico-Thoracic Fixation System by CTL Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal spinal fixation procedure kit, reusable.

Cleared under the same submission

K121136 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CTL Medical Corporation

Sources (1)

  • FDA UDI 72396248-8ca4-4172-9dc7-07004218a1a9 36 fields · synced Jun 8, 2026