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Delta

FDA UDI

Class II (US FDA UDI)

by Stryker Leibinger

Identity

Trade Name
DELTA FDA UDI
Generic Name
Craniofacial bone screw, bioabsorbable FDA UDI
Device Name
DELTA 2.2X6MM SCREW, 4 EA FDA UDI
Model / Reference
70-22406 FDA UDI
Description
DELTA 2.2X6MM SCREW, 4 EA FDA UDI

Identifiers

Catalog Number
70-22406 FDA UDI
Primary DI / UDI-DI
34546540337567 FDA UDI
510(k) Number
K213777 FDA UDI
K993061 FDA UDI
FDA Product Code
MAI FDA UDI
GXR FDA UDI
HBW FDA UDI
JEY FDA UDI
GMDN Term
Craniofacial bone screw, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
882.5250 FDA UDI
882.5360 FDA UDI
872.4760 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
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Length — 6.0 Millimeter FDA UDI

Category: Craniofacial bone screw, bioabsorbable

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

Similar devices

Also classified as Craniofacial bone screw, bioabsorbable.

Cleared under the same submission

K213777 also covers:

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 a7965bd5-80bc-4ae1-ab67-186b760db155 37 fields · synced Jun 6, 2026