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DISCOVERY TiNano ACIF

FDA UDI

Class II (US FDA UDI)

by Aurora Spine, Inc.

Identity

Trade Name
DISCOVERY TiNano ACIF FDA UDI
Generic Name
Polymeric spinal fusion cage, sterile FDA UDI
Device Name
DISCOVERY TiNano ACIF 14mm X 16mm X 5 X 5mm FDA UDI
Model / Reference
105010505 FDA UDI
Description
DISCOVERY TiNano ACIF 14mm X 16mm X 5 X 5mm FDA UDI

Identifiers

Catalog Number
105010505 FDA UDI
Primary DI / UDI-DI
B521105010505 FDA UDI
510(k) Number
K111484 FDA UDI
FDA Product Code
ODP FDA UDI
GMDN Term
Polymeric spinal fusion cage, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
Not 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

No

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

No

FDA UDI

Dimensions & Sizes

Size
Height — 5 Millimeter FDA UDI
Angle — 5 degree FDA UDI
Width — 16 Millimeter FDA UDI
Length — 14 Millimeter FDA UDI

DISCOVERY TiNano ACIF by Aurora Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K111484 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aurora Spine, Inc.

Sources (1)

  • FDA UDI c57be7bd-c1df-4239-96f4-b5a9645ff17f 38 fields · synced Jun 1, 2026