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Karma

FDA UDI

Class II (US FDA UDI)

by Spinal Elements, Inc.

Identity

Trade Name
KARMA FDA UDI
Generic Name
Internal spinal fixation system cable FDA UDI
Device Name
PEEK Cerclage FDA UDI
Model / Reference
R75035-175 FDA UDI
Description
PEEK Cerclage FDA UDI

Identifiers

Primary DI / UDI-DI
00840606116145 FDA UDI
FDA Product Code
OWI FDA UDI
GMDN Term
Internal spinal fixation system cable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Internal spinal fixation system cable

Karma by Spinal Elements, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal spinal fixation system cable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spinal Elements, Inc.

Sources (1)

  • FDA UDI 873b38e3-7508-4be3-b06b-5853342c92fb 33 fields · synced Jun 8, 2026