STAR™

GUDID 00886385026985

Sliding Core, UHMPWE, 12mm REVISION

Stryker Trauma SA

Ankle prosthesis bearing

• Primary Device ID: 00886385026985
• NIH Device Record Key: 4924b96b-5ed6-4576-a6c8-a73b43a9fd58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STAR™
• Version Model Number: 99-0028/12F
• Company DUNS: 481999654
• Company Name: Stryker Trauma SA
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx
• Phone: 1-201-831-5000
• Email: xx@xx.xx

Device Dimensions

• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight or dampness
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight or dampness
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight or dampness
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight or dampness
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight or dampness
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight or dampness
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight or dampness
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight or dampness
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight or dampness
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight or dampness
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight or dampness
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight or dampness
• Storage Environment Humidity: Between 50 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886385026985 [Primary]

FDA Product Code

• NTG: Prosthesis, Ankle, Uncemented, Non-Constrained

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-06-27

On-Brand Devices [STAR™]

• 00886385027074: Silicone Pin Mat
• 00886385027067: STAR Instrumentation Case Base #3
• 00886385027050: STAR Instrumentation Case Base #2
• 00886385027005: Sliding Core, UHMPWE, 14mm REVISION
• 00886385026992: Sliding Core, UHMPWE, 13mm REVISION
• 00886385026985: Sliding Core, UHMPWE, 12mm REVISION
• 00886385026978: Sliding Core, UHMPWE, 11mm REVISION
• 00886385026961: Sliding Core, UHMPWE, 10mm
• 00886385026947: Sliding Core, UHMPWE, 8mm
• 00886385026930: Sliding Core, UHMPWE, 7mm
• 00886385026923: Sliding Core, UHMPWE, 6mm
• 00886385019482: Trial S.T.A.R. P.E. Core 14mm
• 00886385019475: Trial S.T.A.R. P.E. Core 13mm
• 00886385019468: Trial S.T.A.R. P.E. Core 12mm
• 00886385019451: Trial S.T.A.R. P.E. Core 11mm
• 00886385019406: DATUM HOLDER ASSEMBLY
• 00886385019222: DATUM HOLDER/DISTRACTOR
• 00886385019215: ANGEL WING
• 00886385019154: TIBIA BARREL HOLE WEDGE
• 00886385019130: TIBIAL EXTRACTOR TOOL ASSEMBLY
• 00886385019031: Lateral I/M Alignment Assembly
• 00886385019024: PIN PULLER
• 00886385019000: GEAR KEY
• 00886385018980: Tibial Key Hole Cutter, Blade
• 00886385018966: Tibial Key Hole Cutter Assembly
• 00886385018959: JOINT SPACE EVALUATOR
• 00886385018928: Fixation Pin 6.5 x 62mm
• 00886385018911: BARREL HOLE PLATE, XLARGE
• 00886385018904: BARREL HOLE PLATE, LARGE
• 00886385018898: BARREL HOLE PLATE, MEDIUM
• 00886385018881: BARREL HOLE PLATE, SMALL
• 00886385018874: BARREL HOLE PLATE, XS
• 00886385018867: Alignment Pin, 47mm
• 00886385018850: Alignment Pin, 35mm
• 00886385018812: Tibial Alignment Rotation Sleeve Assembly
• 00886385018805: PIN BLOCK ASSEMBLY, SET SCREW
• 00886385018775: PIN BLOCK ASSEMBLY
• 00886385018751: Adjustable Slider Block Assembly, DoveTail Lock
• 00886385018744: Adjustable Slider Block Assembly, Bolt
• 00886385018720: Adjustable Slider Block Assembly
• 00886385018614: TALAR CUT GUIDE CAPTIVE SCREW
• 00886385018607: Forceps, Star Instrumentation
• 00886385018591: Tibial Cut Guide, Captive Screw
• 00886385018584: PE Trial, Size 14
• 00886385018577: PE Trial, Size 13
• 00886385018560: PE Trial, Size 12
• 00886385018553: PE Trial, Size 11
• 00886385018546: PE Trial, Size 10
• 00886385018539: PE Trial, Size 9
• 00886385018522: PE Trial, Size 8