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Optimized Positioning System (OPS)

FDA UDI

Class II (US FDA UDI)

by Optimized Ortho Pty Ltd

Identity

Trade Name
Optimized Positioning System (OPS) FDA UDI
Generic Name
Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Device Name
Patient Specific Acetabular Guide and Trial Acetabulum FDA UDI
Model / Reference
1248-1500 and 1248-1700 FDA UDI
Description
Patient Specific Acetabular Guide and Trial Acetabulum FDA UDI

Identifiers

Primary DI / UDI-DI
09351327000022 FDA UDI
510(k) Number
K152893 FDA UDI
FDA Product Code
MEH FDA UDI
LWJ FDA UDI
LZO FDA UDI
GMDN Term
Custom-made orthopaedic/craniofacial surgical guide FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3353 FDA UDI
888.3360 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Custom-made orthopaedic/craniofacial surgical guide

Optimized Positioning System (OPS) by Optimized Ortho Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made orthopaedic/craniofacial surgical guide.

Cleared under the same submission

K152893 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Optimized Ortho Pty Ltd

Sources (1)

  • FDA UDI 45922bae-44bb-4117-8b1a-51a610c90961 34 fields · synced May 30, 2026