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FDA UDI

Class II (US FDA UDI)

by Aurora Spine, Inc.

Identity

Trade Name
ZIP FDA UDI
Generic Name
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile FDA UDI
Device Name
ZIP ULTRA MIS Interspinous Fusion System, 8mm x 40mm FDA UDI
Model / Reference
ULTRA FDA UDI
Description
ZIP ULTRA MIS Interspinous Fusion System, 8mm x 40mm FDA UDI

Identifiers

Catalog Number
001-008-M-ZIP FDA UDI
Primary DI / UDI-DI
B521001008MZIP0 FDA UDI
510(k) Number
K140715 FDA UDI
FDA Product Code
PEK FDA UDI
GMDN Term
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3050 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

No

FDA UDI

Dimensions & Sizes

Size
Length — 40 Millimeter FDA UDI
Lumen/Inner Diameter — 8 Millimeter FDA UDI

Category: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

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

Similar devices

Also classified as Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile.

Cleared under the same submission

K140715 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 a0074c51-b385-42d1-bbff-0aeed167f3df 37 fields · synced May 31, 2026