← Back to catalogue

Scs Claris Spinal System

FDA UDI

Class I (US FDA UDI)

by Choicespine, LP

Identity

Trade Name
SCS CLARIS SPINAL SYSTEM FDA UDI
Generic Name
Surgical instrument handle, torque-limiting FDA UDI
Device Name
UNIV,T HANDLE, TORQUE,90,SQUARE FDA UDI
Model / Reference
7070-1046 FDA UDI
Description
UNIV,T HANDLE, TORQUE,90,SQUARE FDA UDI

Identifiers

Primary DI / UDI-DI
00840996174695 FDA UDI
510(k) Number
K021379 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Surgical instrument handle, torque-limiting FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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: Surgical instrument handle, torque-limiting

Scs Claris Spinal System by Choicespine, LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument handle, torque-limiting.

Cleared under the same submission

K021379 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
Choicespine, LP

Sources (1)

  • FDA UDI 3958d96b-8137-4db5-bcc2-6aa7b59a33ad 35 fields · synced Jun 8, 2026