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Isola

FDA UDI

Class II (US FDA UDI)

by Depuy Spine, Inc.

Identity

Trade Name
ISOLA FDA UDI
Generic Name
Spinal fixation plate, non-bioabsorbable FDA UDI
Device Name
ISOLA SPINE SYSTEM MCC PLATE 25-40mm FDA UDI
Model / Reference
2030540 FDA UDI
Description
ISOLA SPINE SYSTEM MCC PLATE 25-40mm FDA UDI

Identifiers

Catalog Number
2030540 FDA UDI
Primary DI / UDI-DI
10705034004556 FDA UDI
510(k) Number
K980485 FDA UDI
FDA Product Code
KWQ FDA UDI
KWP FDA UDI
MNH FDA UDI
MNI FDA UDI
GMDN Term
Spinal fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 FDA UDI
888.3050 FDA UDI
888.3070 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

Cleared under the same submission

K980485 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Depuy Spine, Inc.

Sources (1)

  • FDA UDI 7aa8b5fd-8bc2-4082-865f-0436b2c5e2d2 37 fields · synced May 31, 2026