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2.0 Lactosorb System

FDA UDI

Class II (US FDA UDI)

by Biomet Microfixation, Inc

Identity

Trade Name
2.0 LACTOSORB SYSTEM FDA UDI
Generic Name
Craniofacial bone screw, bioabsorbable FDA UDI
Model / Reference
915-2202 FDA UDI

Identifiers

Catalog Number
915-2202 FDA UDI
Primary DI / UDI-DI
00841036054717 FDA UDI
510(k) Number
K011139 FDA UDI
FDA Product Code
HRS FDA UDI
HWC FDA UDI
GMDN Term
Craniofacial bone screw, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
888.3040 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

No

FDA UDI

Category: Craniofacial bone screw, bioabsorbable

2.0 Lactosorb System by Biomet Microfixation, Inc — 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

K011139 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 5bcde629-f456-4008-98a5-0510fc1ebf3c 35 fields · synced Jun 6, 2026