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Delta

FDA UDI

Class II (US FDA UDI)

by Stryker Leibinger

Identity

Trade Name
DELTA FDA UDI
Generic Name
Craniofacial fixation plate, bioabsorbable FDA UDI
Device Name
DELTA 2.2MM DOUBLE Y-PLATE 10HOLE FDA UDI
Model / Reference
70-06168 FDA UDI
Description
DELTA 2.2MM DOUBLE Y-PLATE 10HOLE FDA UDI

Identifiers

Catalog Number
70-06168 FDA UDI
Primary DI / UDI-DI
04546540337290 FDA UDI
510(k) Number
K993061 FDA UDI
FDA Product Code
MAI FDA UDI
GMDN Term
Craniofacial fixation plate, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 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: Craniofacial fixation plate, bioabsorbable

Delta by Stryker Leibinger — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Craniofacial fixation plate, bioabsorbable.

Cleared under the same submission

K993061 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Leibinger

Sources (1)

  • FDA UDI 44b2d728-5df7-4c44-bdbc-f10beac8dee2 37 fields · synced May 30, 2026