Sierra™ 50-5017

GUDID 10889981043018

Occipital Screw, 17mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital pl

SEASPINE ORTHOPEDICS CORPORATION

Cannulated surgical drill bit, single-use, sterile Cannulated surgical drill bit, single-use, sterile Cannulated surgical drill bit, single-use Cannulated surgical drill bit, single-use Cannulated surgical drill bit, single-use Cannulated surgical drill bit, single-use Cannulated surgical drill bit, single-use Cannulated surgical drill bit, single-use Cannulated surgical drill bit, single-use Cannulated surgical drill bit, single-use Cannulated surgical drill bit, single-use Cannulated surgical drill bit, single-use Cannulated surgical drill bit, single-use

• Primary Device ID: 10889981043018
• NIH Device Record Key: b8bb818a-c8fe-4600-8ff5-813909350177
• Commercial Distribution Discontinuation: 2016-09-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Sierra™
• Version Model Number: 50-5017
• Catalog Number: 50-5017
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981043018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062934

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10889981043018]

Moist Heat or Steam Sterilization

[10889981043018]

Moist Heat or Steam Sterilization

[10889981043018]

Moist Heat or Steam Sterilization

[10889981043018]

Moist Heat or Steam Sterilization

[10889981043018]

Moist Heat or Steam Sterilization

[10889981043018]

Moist Heat or Steam Sterilization

[10889981043018]

Moist Heat or Steam Sterilization

[10889981043018]

Moist Heat or Steam Sterilization

[10889981043018]

Moist Heat or Steam Sterilization

[10889981043018]

Moist Heat or Steam Sterilization

[10889981043018]

Moist Heat or Steam Sterilization

[10889981043018]

Moist Heat or Steam Sterilization

[10889981043018]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-11-22
• Device Publish Date: 2015-09-24

On-Brand Devices [Sierra™]

• 10889981062309: Sierra Extended Tab Screw Caddy
• 10889981062293: Sierra Occipital Plate Implant
• 10889981062286: Sierra Implant
• 10889981059163: S2S CrossBar, 33 - 47mm
• 10889981059156: S2S CrossBar, 27 - 35mm
• 10889981059149: S2S CrossBar, 24 - 29mm
• 10889981059132: Sierra Set Screw
• 10889981059125: Axial Rod Connector, 3.5/6.35
• 10889981059118: Axial Rod Connector, 3.5/5.5
• 10889981059101: Axial Rod Connector, 3.5/3.5
• 10889981059095: Parallel Rod Connector, 3.5/6.35, Single
• 10889981059088: Parallel Rod Connector, 3.5/5.5, Single
• 10889981059071: Parallel Rod Connector, 3.5/3.5, Single
• 10889981059064: Parallel Rod Connector, 3.5/6.35, Double
• 10889981059057: Parallel Rod Connector, 3.5/5.5, Double
• 10889981059040: Parallel Rod Connector, 3.5/3.5, Double
• 10889981059033: Connector Set Screw
• 10889981057640: Occipital Plate, 45-55mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, inc
• 10889981057633: Occipital Plate, 40-50mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, inc
• 10889981057626: Occipital Plate, 35-45mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, inc
• 10889981057619: Occipital Plate, 30-40mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, inc
• 10889981057602: Occipital Plate, 25-35mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, inc
• 10889981044022: Sierra Extended Tab Screw, 04.5 x 50mm
• 10889981044015: Sierra Extended Tab Screw, 04.5 x 45mm
• 10889981044008: Sierra Extended Tab Screw, 04.5 x 40mm
• 10889981043995: Sierra Extended Tab Screw, 04.5 x 38mm
• 10889981043988: Sierra Extended Tab Screw, 04.5 x 36mm
• 10889981043971: Sierra Extended Tab Screw, 04.5 x 34mm
• 10889981043964: Sierra Extended Tab Screw, 04.5 x 32mm
• 10889981043957: Sierra Extended Tab Screw, 04.5 x 30mm
• 10889981043940: Sierra Extended Tab Screw, 04.5 x 28mm
• 10889981043933: Sierra Extended Tab Screw, 04.5 x 26mm
• 10889981043926: Sierra Extended Tab Screw, 04.5 x 24mm
• 10889981043919: Sierra Extended Tab Screw, 04.5 x 22mm
• 10889981043902: Sierra Extended Tab Screw, 04.5 x 20mm
• 10889981043896: Sierra Extended Tab Screw, 04.5 x 18mm
• 10889981043889: Sierra Extended Tab Screw, 04.5 x 16mm
• 10889981043872: Sierra Extended Tab Screw, 04.5 x 14mm
• 10889981043865: Sierra Extended Tab Screw, 04.5 x 12mm
• 10889981043858: Sierra Extended Tab Screw, 04.5 x 10mm
• 10889981043841: Sierra Extended Tab Screw, 04.5 x 8mm
• 10889981043834: Sierra Extended Tab Screw, 04.0 x 40mm
• 10889981043827: Sierra Extended Tab Screw, 04.0 x 38mm
• 10889981043810: Sierra Extended Tab Screw, 04.0 x 36mm
• 10889981043803: Sierra Extended Tab Screw, 04.0 x 34mm
• 10889981043797: Sierra Extended Tab Screw, 04.0 x 32mm
• 10889981043780: Sierra Extended Tab Screw, 04.0 x 30mm
• 10889981043773: Sierra Extended Tab Screw, 04.0 x 28mm
• 10889981043766: Sierra Extended Tab Screw, 04.0 x 26mm
• 10889981043759: Sierra Extended Tab Screw, 04.0 x 14mm