← Back to catalogue

Spike Driver, 8-9mm

FDA UDI

Class II (US FDA UDI)

by Elevation Spine

Identity

Trade Name
Spike Driver, 8-9mm FDA UDI
Generic Name
Internal spinal fixation procedure kit, single-use FDA UDI
Device Name
Spike Driver, 8-9mm FDA UDI
Model / Reference
CI-DRIVER3-SP-89 FDA UDI
Description
Spike Driver, 8-9mm FDA UDI

Identifiers

Catalog Number
CI-DRIVER3-SP-89 FDA UDI
Primary DI / UDI-DI
00810017913558 FDA UDI
510(k) Number
K190885 FDA UDI
FDA Product Code
ODP FDA UDI
OVE FDA UDI
KWQ FDA UDI
GMDN Term
Internal spinal fixation procedure kit, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
888.3060 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Internal spinal fixation procedure kit, single-use

Spike Driver, 8-9mm by Elevation Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal spinal fixation procedure kit, single-use.

Cleared under the same submission

K190885 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
Elevation Spine

Sources (1)

  • FDA UDI 65f85d06-4e61-4173-a32d-d7a2d908e0de 36 fields · synced May 30, 2026