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) (10) Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented (LWJ) (10) Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate (MEH) (10)

Premarket Exempt

Clear

Optimized Ortho Positioning (OPS) System - 09351327000602 Catalog Number :

Device Description : T-Handle Introducer

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 - 09351327000619 Catalog Number :

Device Description : Pelvic Screw Long

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 - 09351327000626 Catalog Number :

Device Description : Pelvic Screw Short

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 - 09351327000633 Catalog Number :

Device Description : Pelvic Screw Attachment

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 - 09351327000640 Catalog Number :

Device Description : Laser Canister Cap

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 - 09351327000657 Catalog Number :

Device Description : Laser Canister

Device Class : 2

Duns Number: 745735175

Premarket Exempt : No

Product Code : LZO, LWJ, MEH

Prescription Use : Yes

Device Count : 1

OPS - 09351327000664 Catalog Number :

Device Description : Reference Post

Device Class : 2

Duns Number: 745735175

Premarket Exempt : No

Product Code : LZO, LWJ, MEH

Prescription Use : Yes

Device Count : 1

OPS - 09351327000671 Catalog Number :

Device Description : Canister Clamp

Device Class : 2

Duns Number: 745735175

Premarket Exempt : No

Product Code : LZO, LWJ, MEH

Prescription Use : Yes

Device Count : 1

OPS - 09351327000688 Catalog Number :

Device Description : Reamer Adaptor Stryker

Device Class : 2

Duns Number: 745735175

Premarket Exempt : No

Product Code : LZO, LWJ, MEH

Prescription Use : Yes

Device Count : 1

OPS - 09351327000695 Catalog Number :

Device Description : Impactor Canister Adaptor 42.5mm

Device Class : 2

Duns Number: 745735175

Premarket Exempt : No

Product Code : LZO, LWJ, MEH

Prescription Use : Yes

Device Count : 1

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