DEPUY MITEK, LLC

Address:325 Paramount Dr,RAYNHAM,MA,02767,US

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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

FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE (MAI) (9) Suture, nonabsorbable, synthetic, polyester (GAS) (3) SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID (GAM) (3) SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE (GAT) (3) Screw, fixation, bone (HWC) (3) FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE (MBI) (2) PIN, FIXATION, SMOOTH (HTY) (2) ARTHROSCOPE (HRX) (1) SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE (NEW) (1)

Premarket Exempt

No Yes

Clear

LUPINE ORTHOCORD - 10886705001095 Catalog Number : 210711

Device Description : LUPINE BR ANCHOR w/ORTHOCORD TCP/PLGA Absorbable Anchor, size 2 (5 metric) braid LUPINE BR ANCHOR w/ORTHOCORD TCP/PLGA Absorbable Anchor, size 2 (5 metric) braided composite suture, violet 36 Inches (91cm). Size 2 (5 metric) eyelet loop.

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : GAS, MAI, GAM, GAT

Prescription Use : Yes

Device Count : 1

LUPINE ORTHOCORD - 10886705001101 Catalog Number : 210712

Device Description : LUPINE BR Anchor W/DS ORTHOCORD TCP/PLGA Absorbable Anchor, with dual size 2 (5 LUPINE BR Anchor W/DS ORTHOCORD TCP/PLGA Absorbable Anchor, with dual size 2 (5 metric) braided composite suture, violet and blue, 36 Inches (91cm). Size 2 (5 metric) eyelet loop.

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : GAT, GAS, GAM, MAI

Prescription Use : Yes

Device Count : 1

PANALOK PANACRYL - 10886705001156 Catalog Number : 210725

Device Description : PANALOK Absorbable Anchor 3.5mm Size 2 (5 metric) PANACRYL absorbable braided su PANALOK Absorbable Anchor 3.5mm Size 2 (5 metric) PANACRYL absorbable braided suture, 36 Inches (91cm), double-armed with CP-2 needles, with disposable inserter.

Device Class : 2

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : MAI, HRX, MBI

Prescription Use : Yes

Device Count : 1

VERSALOK ORTHOCORD - 10886705001224 Catalog Number : 210808

Device Description : VERSALOK ANCHOR w/ORTHOCORD PEEK & Titanium Anchor (1) Violet (1) Blue Strand, S VERSALOK ANCHOR w/ORTHOCORD PEEK & Titanium Anchor (1) Violet (1) Blue Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm)

Device Class : 2

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : GAT, HWC, GAS, GAM, NEW, MBI

Prescription Use : Yes

Device Count : 1

GRYPHON ORTHOCORD - 10886705001255 Catalog Number : 210811

Device Description : GRYPHON T BR DS Anchor w/ORTHOCORD TCP/PLGA Absorbable Anchor (1) Violet (1) Blu GRYPHON T BR DS Anchor w/ORTHOCORD TCP/PLGA Absorbable Anchor (1) Violet (1) Blue Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm)

Device Class : 2

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : MAI

Prescription Use : Yes

Device Count : 1

GRYPHON ORTHOCORD - 10886705001262 Catalog Number : 210812

Device Description : GRYPHON T BR Anchor w/ORTHOCORD TCP/PLGA Absorbable Anchor, (1) Violet Strand, S GRYPHON T BR Anchor w/ORTHOCORD TCP/PLGA Absorbable Anchor, (1) Violet Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm)

Device Class : 2

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : MAI

Prescription Use : Yes

Device Count : 1

GRYPHON ORTHOCORD - 10886705001279 Catalog Number : 210813

Device Description : GRYPHON P BR DS Anchor w/ORTHOCORD TCP/PLGA Absorbable Anchor (1) Violet (1) Blu GRYPHON P BR DS Anchor w/ORTHOCORD TCP/PLGA Absorbable Anchor (1) Violet (1) Blue Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm)

Device Class : 2

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : MAI

Prescription Use : Yes

Device Count : 1

GRYPHON ORTHOCORD - 10886705001286 Catalog Number : 210814

Device Description : GRYPHON P BR Anchor w/ORTHOCORD TCP/ PLGA Absorbable Anchor, (1) Violet Strand, GRYPHON P BR Anchor w/ORTHOCORD TCP/ PLGA Absorbable Anchor, (1) Violet Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm)

Device Class : 2

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : MAI

Prescription Use : Yes

Device Count : 1

RIGIDFIX BIOCRYL - 10886705001293 Catalog Number : 210815

Device Description : RIGIDFIX BIOCRYL BTB CROSS PIN KIT (2) each BTB Cross Pins, 2.7mm x 42mm BIOCRYL RIGIDFIX BIOCRYL BTB CROSS PIN KIT (2) each BTB Cross Pins, 2.7mm x 42mm BIOCRYL (TCP/PLA), (2) each Sleeve Assemblies, and (1) each Interlocking Trocar

Device Class : 2

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : MAI, HWC, HTY

Prescription Use : Yes

Device Count : 1

RIGIDFIX BIOCRYL - 10886705001309 Catalog Number : 210816

Device Description : RIGIDFIX BIOCRYL FEMORAL ST CROSS PIN KIT (2) each ST Cross Pins, 3.3mm x 42mm B RIGIDFIX BIOCRYL FEMORAL ST CROSS PIN KIT (2) each ST Cross Pins, 3.3mm x 42mm BIOCRYL (TCP/PLA), (2) each Sleeve Assemblies, and (1) each Interlocking Trocar

Device Class : 2

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : MAI, HTY, HWC

Prescription Use : Yes

Device Count : 1

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