8.5 x 55mm CANN EXTENSION FASTENER 101-85055

GUDID 00810097802063

8.5 x 55mm CANN EXTENSION FASTENER

SMV SCIENTIFIC LLC

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00810097802063
NIH Device Record Key90ff75ac-1789-44cb-abdb-ebc5089aaa88
Commercial Distribution StatusIn Commercial Distribution
Brand Name8.5 x 55mm CANN EXTENSION FASTENER
Version Model Number101-85055
Catalog Number101-85055
Company DUNS089645059
Company NameSMV SCIENTIFIC LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com

Device Dimensions

Outer Diameter8.5 Millimeter
Length55 Millimeter
Outer Diameter8.5 Millimeter
Length55 Millimeter
Outer Diameter8.5 Millimeter
Length55 Millimeter
Outer Diameter8.5 Millimeter
Length55 Millimeter
Outer Diameter8.5 Millimeter
Length55 Millimeter
Outer Diameter8.5 Millimeter
Length55 Millimeter
Outer Diameter8.5 Millimeter
Length55 Millimeter
Outer Diameter8.5 Millimeter
Length55 Millimeter
Outer Diameter8.5 Millimeter
Length55 Millimeter
Outer Diameter8.5 Millimeter
Length55 Millimeter
Outer Diameter8.5 Millimeter
Length55 Millimeter
Outer Diameter8.5 Millimeter
Length55 Millimeter
Outer Diameter8.5 Millimeter
Length55 Millimeter
Outer Diameter8.5 Millimeter
Length55 Millimeter
Outer Diameter8.5 Millimeter
Length55 Millimeter
Outer Diameter8.5 Millimeter
Length55 Millimeter
Outer Diameter8.5 Millimeter
Length55 Millimeter
Outer Diameter8.5 Millimeter
Length55 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810097802063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810097802063]

Moist Heat or Steam Sterilization

[00810097802063]

Moist Heat or Steam Sterilization

[00810097802063]

Moist Heat or Steam Sterilization

[00810097802063]

Moist Heat or Steam Sterilization

[00810097802063]

Moist Heat or Steam Sterilization

[00810097802063]

Moist Heat or Steam Sterilization

[00810097802063]

Moist Heat or Steam Sterilization

[00810097802063]

Moist Heat or Steam Sterilization

[00810097802063]

Moist Heat or Steam Sterilization

[00810097802063]

Moist Heat or Steam Sterilization

[00810097802063]

Moist Heat or Steam Sterilization

[00810097802063]

Moist Heat or Steam Sterilization

[00810097802063]

Moist Heat or Steam Sterilization

[00810097802063]

Moist Heat or Steam Sterilization

[00810097802063]

Moist Heat or Steam Sterilization

[00810097802063]

Moist Heat or Steam Sterilization

[00810097802063]

Moist Heat or Steam Sterilization

[00810097802063]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-21
Device Publish Date2023-04-13

Devices Manufactured by SMV SCIENTIFIC LLC

00810074300001 - 4.0 x 12mm Screw Super Fastener, ST2023-06-20 4.0 x 12mm Screw Super Fastener, ST
00810074300018 - 4.0 x 14mm Screw Super Fastener, ST2023-06-20 4.0 x 14mm Screw Super Fastener, ST
00810074300025 - 4.0 x 16mm Screw Super Fastener, ST2023-06-20 4.0 x 16mm Screw Super Fastener, ST
00810074300032 - 4.0 x 18mm Screw Super Fastener, ST2023-06-20 4.0 x 18mm Screw Super Fastener, ST
00810074300049 - 4.0 x 20mm Screw Super Fastener, ST2023-06-20 4.0 x 20mm Screw Super Fastener, ST
00810074300056 - 4.0 x 22mm Screw Super Fastener, ST2023-06-20 4.0 x 22mm Screw Super Fastener, ST
00810074300063 - 4.0 x 24mm Screw Super Fastener, ST2023-06-20 4.0 x 24mm Screw Super Fastener, ST
00810074300070 - 4.0 x 26mm Screw Super Fastener, ST2023-06-20 4.0 x 26mm Screw Super Fastener, ST
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.