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Trial Head 15x18x8 12 deg.

FDA UDI

Class II (US FDA UDI)

by Elevation Spine

Identity

Trade Name
Trial Head 15x18x8 12 deg. FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
Trial Head 15x18x8 12 deg. FDA UDI
Model / Reference
CI-TH5828 FDA UDI
Description
Trial Head 15x18x8 12 deg. FDA UDI

Identifiers

Catalog Number
CI-TH5828 FDA UDI
Primary DI / UDI-DI
00810017915088 FDA UDI
510(k) Number
K190885 FDA UDI
FDA Product Code
ODP FDA UDI
OVE FDA UDI
KWQ FDA UDI
GMDN Term
Spinal implant trial 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Spinal implant trial

Trial Head 15x18x8 12 deg. by Elevation Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal implant trial.

Cleared under the same submission

K190885 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elevation Spine

Sources (1)

  • FDA UDI 2f0e4585-0bcd-4cf1-aec3-fccf07771ebb 36 fields · synced May 30, 2026