OPTIMIZED ORTHO PTY LTD

Address:17 Bridge Street,Sydney New South Wales,AU

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (LZO) (4) Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented (LWJ) (4) Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate (MEH) (4) System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

Clear

OPS - 09351327000824 Catalog Number :

Device Description : Curved Guide Handle Post

Device Class : 2

Duns Number: 745735175

Premarket Exempt : No

Product Code : LZO, LWJ, MEH

Prescription Use : Yes

Device Count : 1

OPS - 09351327000831 Catalog Number :

Device Description : Impactor Canister Dual Adaptor

Device Class : 2

Duns Number: 745735175

Premarket Exempt : No

Product Code : LZO, LWJ, MEH

Prescription Use : Yes

Device Count : 1

OPSInsight™ - 09351327000848 Catalog Number : 1200-0000

Device Description : OPSInsight™ is intended for use as preoperative surgical planning software to ai OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.

Device Class : 2

Duns Number: 745735175

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Optimized Ortho Positioning (OPS) System - 09351327001302 Catalog Number :

Device Description : OPS Reusable Instrument Inner Tray

Device Class : 2

Duns Number: 745735175

Premarket Exempt : No

Product Code : LZO, LWJ, MEH

Prescription Use : Yes

Device Count : 1

Optimized Ortho Positioning (OPS) System - 09351327001364 Catalog Number :

Device Description : OPS Reusable Instrument Outer Tray with Lid

Device Class : 2

Duns Number: 745735175

Premarket Exempt : No

Product Code : LZO, LWJ, MEH

Prescription Use : Yes

Device Count : 1

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