← Back to catalogue

Spike Implants

FDA UDI

Class II (US FDA UDI)

by Elevation Spine

Identity

Trade Name
Spike Implants FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
Saber-C 14mm Spikes (No Carriage) FDA UDI
Model / Reference
CQ-14 FDA UDI
Description
Saber-C 14mm Spikes (No Carriage) FDA UDI

Identifiers

Primary DI / UDI-DI
00810017915279 FDA UDI
510(k) Number
K190885 FDA UDI
FDA Product Code
KWQ FDA UDI
ODP FDA UDI
OVE FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Spinal bone screw, non-bioabsorbable

Spike Implants by Elevation Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal bone screw, non-bioabsorbable.

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 b4e8f6c3-4560-4840-bbf2-db04d0cb1af9 35 fields · synced May 31, 2026