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) (4) Wrap, Sterilization (FRG) (2) Forceps, Rongeur, Surgical (EMH) (1) Impactor (HWA) (1) Pliers, Surgical (HTC) (1) Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (KCT) (1)

Premarket Exempt

No Yes

Clear

AA HIP BROACH HANDLE SET - 00847538011333 Catalog Number : 259807026

Device Description : AA HIP BROACH HANDLE SET

Device Class : 2

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : Yes

Device Count : 1

DePuy Sythes - 00847538011340 Catalog Number : 259807027

Device Description : AA BROACH CASE OUTER

Device Class : 2

Duns Number: 079881212

Premarket Exempt : No

Product Code : FRG

Prescription Use : Yes

Device Count : 1

DePuy Sythes - 00847538011357 Catalog Number : 259807028

Device Description : AA BROACH CASE LID

Device Class : 2

Duns Number: 079881212

Premarket Exempt : No

Product Code : FRG

Prescription Use : Yes

Device Count : 1

Long Rongeur w/ Ratchet Handle - 00847538015713 Catalog Number : 2709-01-016

Device Description : Long Rongeur w/ Ratchet Handle

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : EMH

Prescription Use : Yes

Device Count : 1

Vise Grips - 00847538015720 Catalog Number : 2709-03-006

Device Description : Vise Grips

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : HTC

Prescription Use : Yes

Device Count : 1

Adapter Slaphammer to Locking Pliers - 00847538015751 Catalog Number : 2011-03-046

Device Description : Adapter Slaphammer to Locking Pliers

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Stem Trial Remover Slaphammer adapter - 00847538015768 Catalog Number : 2011-03-047

Device Description : Stem Trial Remover Slaphammer adapter

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Tibial Component Extractor - 00847538015775 Catalog Number : 2011-03-045

Device Description : Tibial Component Extractor

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Reduction Forcep w/Points - 00847538015805 Catalog Number : 74-263-000

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Smith & Nephew TIP INSERT - OFFSET CUP IMPACTOR - 00847538015935 Catalog Number :

Device Class : 1

Duns Number: 079881212

Premarket Exempt : Yes

Product Code : HWA

Prescription Use : Yes

Device Count : 1

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