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Bone Fixation Screw Kit

FDA UDI

Class II (US FDA UDI)

by Jeil Medical Corporation

Identity

Trade Name
Bone Fixation Screw Kit FDA UDI
Generic Name
Craniofacial fixation plate kit, non-bioabsorbable FDA UDI
Model / Reference
112-080 KIT FDA UDI

Identifiers

Primary DI / UDI-DI
08806390852135 FDA UDI
510(k) Number
K050669 FDA UDI
FDA Product Code
DZL FDA UDI
GMDN Term
Craniofacial fixation plate kit, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4880 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Craniofacial fixation plate kit, non-bioabsorbable

Bone Fixation Screw Kit by Jeil Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Craniofacial fixation plate kit, non-bioabsorbable.

Cleared under the same submission

K050669 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Jeil Medical Corporation

Sources (1)

  • FDA UDI 264e8d5d-77e1-4d5e-949a-bc33fcf30aa0 33 fields · synced Jun 8, 2026