STARR FRAME LLC

Address:1401 N. Central Expressway,Richardson,TX,75080,US

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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) (8) Pin, Fixation, Threaded (JDW) (2)

Premarket Exempt

No Yes

Clear

Starr Frame Half Pin - 00854226007004 Catalog Number : SF-2500-6101

Device Description : Starr Frame Half Pin, 500mm6mm, 500 x 100mm1 each

Device Class : 2

Duns Number: 804185838

Premarket Exempt : No

Product Code : JDW

Prescription Use : Yes

Device Count : 1

Reinert Reduction Tool, 11mm - 00854226007028 Catalog Number : SF-8800-5010

Device Description : Orthopedic manual surgical instrument

Device Class : 1

Duns Number: 804185838

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Starr Frame Half Pin - 00854226007035 Catalog Number : SF-2250-5051

Device Description : Starr Frame Half Pin5mm, 250 x 50mm1 each

Device Class : 2

Duns Number: 804185838

Premarket Exempt : No

Product Code : JDW

Prescription Use : No

Device Count : 1

Reinert Reduction Tool, 10.5mm - 00854226007059 Catalog Number : SF-8800-5015

Device Description : Orthopedic manual surgical instrument

Device Class : 1

Duns Number: 804185838

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Ball Spike - 00854226007066 Catalog Number : SF-8800-5020

Device Description : Orthopedic manual surgical instrument

Device Class : 1

Duns Number: 804185838

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Hook - 00854226007073 Catalog Number : SF-8800-5030

Device Description : Orthopedic manual surgical instrument

Device Class : 1

Duns Number: 804185838

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Paddle - 00854226007080 Catalog Number : SF-8800-5040

Device Description : Orthopedic manual surgical instrument

Device Class : 1

Duns Number: 804185838

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Pry Bar - 00854226007097 Catalog Number : SF-8800-5050

Device Description : Orthopedic manual surgical instrument

Device Class : 1

Duns Number: 804185838

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Tommy Bar - 00854226007103 Catalog Number : SF-8800-5060

Device Description : Orthopedic manual surgical instrument

Device Class : 1

Duns Number: 804185838

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

AL Quick Connector - 00854226007110 Catalog Number : SF-8800-6010

Device Description : Orthopedic manual surgical instrument

Device Class : 1

Duns Number: 804185838

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

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