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Optimiized Positioning System(OPS) and Optimized Postioning System(OPS)Femoral

FDA UDI

Class II (US FDA UDI)

by Optimized Ortho Pty Ltd

Identity

Trade Name
Optimiized Positioning System(OPS) and Optimized Postioning System(OPS)Femoral FDA UDI
Generic Name
Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Device Name
Patient Specific Acetabular Guide ,Trial Acetabulum,Patient Specific Femoral Guide and Trial Femoral Head FDA UDI
Model / Reference
1248-1500, 1248-1700, 1250-1100,1250-1200 FDA UDI
Description
Patient Specific Acetabular Guide ,Trial Acetabulum,Patient Specific Femoral Guide and Trial Femoral Head FDA UDI

Identifiers

Primary DI / UDI-DI
09351327000060 FDA UDI
510(k) Number
K152893 FDA UDI
K181061 FDA UDI
FDA Product Code
PBF FDA UDI
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
888.3030 FDA UDI
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

Optimiized Positioning System(OPS) and Optimized Postioning System(OPS)Femoral by Optimized Ortho Pty Ltd — Class II — FDA UDI — listed in FDA GUDID

Similar devices

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

Cleared under the same submission

K152893 also covers:

K181061 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 5198be01-ffed-4618-9eef-1aeffb302fa8 34 fields · synced May 30, 2026