SYMMETRY MEDICAL INC.

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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

Orthopedic Manual Surgical Instrument (LXH) (6) Impactor (HWA) (2) Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (HSD) (2) Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (KWS) (2) Shoulder Prosthesis, Reverse Configuration (PHX) (2)

Premarket Exempt

No Yes

Clear

Smith & Nephew 3/8 UNC CUP IMPACTOR SN - CUP IMPACTOR PACK - 00847538015942 Catalog Number :

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : HWA

Prescription Use : Yes

Device Count : 1

Smith & Nephew ANTEVERSION GUIDE - OFFSET CUP IMPACTOR - 00847538016031 Catalog Number :

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : HWA

Prescription Use : Yes

Device Count : 1

GLOBAL UNITE™ Short Stem Instrumentation - 00847538018547 Catalog Number :

Device Description : SHORT PRX HUM BROSTEOTOME 8MM

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

GLOBAL UNITE™ Short Stem Instrumentation - 00847538018554 Catalog Number :

Device Description : SHORT PRX HUM BROSTEOTOME 10MM

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

GLOBAL UNITE™ Short Stem Instrumentation - 00847538018561 Catalog Number :

Device Description : SHORT PRX HUM BROSTEOTOME 12MM

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

GLOBAL UNITE™ Short Stem Instrumentation - 00847538018578 Catalog Number :

Device Description : SHORT PRX HUM BROSTEOTOME 14MM

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

GLOBAL UNITE™ Short Stem Instrumentation - 00847538018585 Catalog Number :

Device Description : SHORT PRX HUM BROSTEOTOME 16MM

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

GLOBAL UNITE™ Short Stem Instrumentation - 00847538018592 Catalog Number :

Device Description : SHORT ASSEMBLY WRENCH

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

GLOBAL UNITE™ Short Stem Instrumentation - 00847538018615 Catalog Number :

Device Description : SHORT PRX HUM REAMGUIDE 8 155

Device Class : 2

Duns Number: 079881212

Premarket Exempt : No

Product Code : PHX, KWS, HSD

Prescription Use : Yes

Device Count : 1

GLOBAL UNITE™ Short Stem Instrumentation - 00847538018622 Catalog Number :

Device Description : SHORT PRX HUM REAMGUIDE 10 155

Device Class : 2

Duns Number: 079881212

Premarket Exempt : No

Product Code : PHX, KWS, HSD

Prescription Use : Yes

Device Count : 1

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