Osteofit LLC

Address:24 Sherwood Lane,Fairfield,NJ,07004,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

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment (HWE) (7)

Premarket Exempt

Yes

Clear

46mm Single-Use Acetabular Reamer - 00850032869003 Catalog Number : 11-100-0046

Device Class : 1

Duns Number: 020886963

Premarket Exempt : Yes

Product Code : HWE

Prescription Use : Yes

Device Count : 1

48mm Single-Use Acetabular Reamer - 00850032869010 Catalog Number : 11-100-0048

Device Class : 1

Duns Number: 020886963

Premarket Exempt : Yes

Product Code : HWE

Prescription Use : Yes

Device Count : 1

50mm Single-Use Acetabular Reamer - 00850032869027 Catalog Number : 11-100-0050

Device Class : 1

Duns Number: 020886963

Premarket Exempt : Yes

Product Code : HWE

Prescription Use : Yes

Device Count : 1

52mm Single-Use Acetabular Reamer - 00850032869034 Catalog Number : 11-100-0052

Device Class : 1

Duns Number: 020886963

Premarket Exempt : Yes

Product Code : HWE

Prescription Use : Yes

Device Count : 1

54mm Single-Use Acetabular Reamer - 00850032869041 Catalog Number : 11-100-0054

Device Class : 1

Duns Number: 020886963

Premarket Exempt : Yes

Product Code : HWE

Prescription Use : Yes

Device Count : 1

56mm Single-Use Acetabular Reamer - 00850032869058 Catalog Number : 11-100-0056

Device Class : 1

Duns Number: 020886963

Premarket Exempt : Yes

Product Code : HWE

Prescription Use : Yes

Device Count : 1

58mm Single-Use Acetabular Reamer - 00850032869065 Catalog Number : 11-100-0058

Device Class : 1

Duns Number: 020886963

Premarket Exempt : Yes

Product Code : HWE

Prescription Use : Yes

Device Count : 1

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