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 1.7MM LADDER PLATE 2X5 HOLE FDA UDI
Model / Reference: 70-05330 FDA UDI
Description: DELTA 1.7MM LADDER PLATE 2X5 HOLE FDA UDI

Identifiers

Catalog Number: 70-05330 FDA UDI
Primary DI / UDI-DI: 04546540337191 FDA UDI
510(k) Number: K213777 FDA UDI
K993061 FDA UDI
FDA Product Code: MAI FDA UDI
HBW FDA UDI
GXR FDA UDI
JEY FDA UDI
GMDN Term: Craniofacial fixation plate, bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
882.5360 FDA UDI
882.5250 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe 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.

RESORB X, STERILE — KLS-Martin L.P. · Class II
RESORB X, STERILE — KLS-Martin L.P. · Class II
LACTOSORB SYSTEM — BIOMET MICROFIXATION, INC · Class II
RapidSorb — Synthes · Class II
1.5 LACTOSORB SYSTEM — BIOMET MICROFIXATION, INC · Class II
RapidSorb — Synthes · Class II
LACTOSORB SYSTEM — BIOMET MICROFIXATION, INC · Class II
RESORB XG, STERILE — KLS-Martin L.P. · Class II

Cleared under the same submission

K213777 also covers:

K993061 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Stryker Leibinger

Sources (1)

FDA UDI c0e1b75f-cec8-4f70-8803-fa2642211b78 37 fields · synced May 30, 2026