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Lactosorb System

FDA UDI

Class II (US FDA UDI)

by Biomet Microfixation, Inc

Identity

Trade Name
LACTOSORB SYSTEM FDA UDI
Generic Name
Craniofacial fixation plate, bioabsorbable FDA UDI
Model / Reference
915-2822 FDA UDI

Identifiers

Catalog Number
915-2822 FDA UDI
Primary DI / UDI-DI
00841036195328 FDA UDI
510(k) Number
K980927 FDA UDI
FDA Product Code
JEY FDA UDI
GMDN Term
Craniofacial fixation plate, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4760 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Lactosorb System by Biomet Microfixation, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K980927 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet Microfixation, Inc

Sources (1)

  • FDA UDI 5020927e-b70d-4f1e-b1d2-1d5181ef9e88 36 fields · synced Jun 8, 2026