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Orthosize Digital Templating Software

FDA UDIFDA 510(k)

Class II (US FDA UDI)

510(k) K120115

by Biomet Orthopedics, Inc.

Identity

Trade Name
Orthosize Digital Templating Software FDA UDI
Generic Name
Orthopaedic/craniofacial implantation planning software FDA UDI
Model / Reference
9999997 FDA UDI

Identifiers

Catalog Number
9999997 FDA UDI
Primary DI / UDI-DI
00887868306709 FDA UDI
510(k) Number
K120115 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Orthopaedic/craniofacial implantation planning software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 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

Category: Orthopaedic/craniofacial implantation planning software

Orthosize Digital Templating Software by Biomet Orthopedics, Inc. — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic/craniofacial implantation planning software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biomet Orthopedics, Inc.
FDA Applicant
Orthosize, LLC

Sources (2)

  • FDA UDI 2e7b0098-34f1-4e74-b08b-f582b4e578fb 58 fields · synced Jun 18, 2026
  • FDA 510(k) K120115 1 fields · synced May 22, 2026