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) (9)

Premarket Exempt

Clear

OPS - 09351327000701 Catalog Number :

Device Description : Right Angle Clamp

Device Class : 2

Duns Number: 745735175

Premarket Exempt : No

Product Code : LZO, LWJ, MEH

Prescription Use : Yes

Device Count : 1

OPS - 09351327000718 Catalog Number :

Device Description : Reference Arm Short

Device Class : 2

Duns Number: 745735175

Premarket Exempt : No

Product Code : LZO, LWJ, MEH

Prescription Use : Yes

Device Count : 1

OPS - 09351327000725 Catalog Number :

Device Description : Reference Arm Long

Device Class : 2

Duns Number: 745735175

Premarket Exempt : No

Product Code : LZO, LWJ, MEH

Prescription Use : Yes

Device Count : 1

OPS - 09351327000732 Catalog Number :

Device Description : Short Curved Guide Handle

Device Class : 2

Duns Number: 745735175

Premarket Exempt : No

Product Code : LZO, LWJ, MEH

Prescription Use : Yes

Device Count : 1

OPS - 09351327000749 Catalog Number :

Device Description : Long Curved Guide Handle

Device Class : 2

Duns Number: 745735175

Premarket Exempt : No

Product Code : LZO, LWJ, MEH

Prescription Use : Yes

Device Count : 1

OPS - 09351327000756 Catalog Number :

Device Description : Short Curved Guide Handle Screw

Device Class : 2

Duns Number: 745735175

Premarket Exempt : No

Product Code : LZO, LWJ, MEH

Prescription Use : Yes

Device Count : 1

OPS - 09351327000763 Catalog Number :

Device Description : Short Curved Guide Handle Screwdriver

Device Class : 2

Duns Number: 745735175

Premarket Exempt : No

Product Code : LZO, LWJ, MEH

Prescription Use : Yes

Device Count : 1

OPS - 09351327000770 Catalog Number :

Device Description : Impactor Canister Adaptor 45mm

Device Class : 2

Duns Number: 745735175

Premarket Exempt : No

Product Code : LZO, LWJ, MEH

Prescription Use : Yes

Device Count : 1

OPS - 09351327000800 Catalog Number :

Device Description : T-Handle Hex Key

Device Class : 2

Duns Number: 745735175

Premarket Exempt : No

Product Code : LZO, LWJ

Prescription Use : Yes

Device Count : 1

OPS - 09351327000817 Catalog Number :

Device Description : Curved Guide Handle

Device Class : 2

Duns Number: 745735175

Premarket Exempt : No

Product Code : LZO, LWJ, MEH

Prescription Use : Yes

Device Count : 1

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