METRIC MEDICAL DEVICES, INC.

Address:846 SILVER SPGS,Helotes,TX,78023,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

Pin, Fixation, Smooth (HTY) (6)

Premarket Exempt

Clear

Intramedullary Fixation Scaffold (IFS) - M9632565L30 Catalog Number : 2565L3

Device Description : Product received FDA 510(k) clearance for: small bone fixation, reconstruction a Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol IFS implant held in instrument with a locking pin, 1ea 1.1mm (0.045") double trocar K-wire with sharps protection, and 1ea 2.7mm Drill Bit with integral handle for manual use.

Device Class : 2

Duns Number: 830255506

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Intramedullary Fixation Scaffold (IFS) - M9632565S30 Catalog Number : 2565S3

Device Description : Product received FDA 510(k) clearance for: small bone fixation, reconstruction a Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol IFS implant held in instrument with a locking pin; 1ea 1.1mm (0.045") Double trocar K-wire with sharps protection, and 1ea 2.7mm Drill Bit with integral handle for manual use.

Device Class : 2

Duns Number: 830255506

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Intramedullary Fixation Scaffold (IFS) - M9632585L30 Catalog Number : 2585L3

Device Description : Product received FDA 510(k) clearance for: small bone fixation, reconstruction a Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains; 1ea Instrument containing a Nitinol IFS implant held in instrument with a locking pin; 1ea 1.1mm (0.045") double trocar k-wire with sharps protection, and 1ea 2.7mm Drill Bit with integral handle for manual use.

Device Class : 2

Duns Number: 830255506

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Intramedullary Fixation Scaffold (IFS) - M9632585S20 Catalog Number : 2585S2

Device Description : 'Product received FDA 510(k) clearance for: small bone fixation, reconstruction 'Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol IFS implant held in place with a locking pin; 1ea 1.1mm (0.045") Double trocar K-wire with sharps protection, and 1ea 2.7mm Drill Bit with handle for manual use.

Device Class : 2

Duns Number: 830255506

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Intramedullary Fixation Scaffold (IFS) - M9632585S30 Catalog Number : 2585S3

Device Description : Product received FDA 510(k) clearance for: small bone fixation, reconstruction a Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains; 1ea Instrument containing a Nitinol IFS implant held in instrument with a locking pin; 1ea 1.1mm (0.045") double trocar k-wire with sharps protection, and 1ea 2.7mm Drill Bit with integral handle for manual use.

Device Class : 2

Duns Number: 830255506

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Intramedullary Fixation Scaffold (IFS) - M963IFS250 Catalog Number : IFS2.5

Device Description : Product received FDA 510(k) clearance for: small bone fixation, reconstruction a Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol IFS implant held in instrument with a locking pin; 3ea K-wires with sharps protection, and 1ea Drill Bit with integral handle for manual use.

Device Class : 2

Duns Number: 830255506

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

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