RIGIDFIX 213015

GUDID 20886705020017

RIGIDFIX CURVE ST ACL PEEK Cross Pin System (2) each ST Cross Pins, 3.3mm x 42mm PEEK, (2) each Sleeve Assemblies, (1) each Interlocking Trocar, (1) P

DEPUY MITEK, LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 20886705020017
• NIH Device Record Key: c0a9534e-dc3d-4363-85eb-e048391d0179
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIGIDFIX
• Version Model Number: 213015
• Catalog Number: 213015
• Company DUNS: 190572854
• Company Name: DEPUY MITEK, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	20886705020017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130105

FDA Product Code

• MAI: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-21
• Device Publish Date: 2015-09-01

On-Brand Devices [RIGIDFIX]

• 20886705020017: RIGIDFIX CURVE ST ACL PEEK Cross Pin System (2) each ST Cross Pins, 3.3mm x 42mm PEEK, (2) each
• 20886705020000: RIGIDFIX CURVE ST ACL PLA Cross Pin System (2) each ST Cross Pins, 3.3mm x 42mm Poly Lactic Acid
• 10886705002986: RIGIDFIX Femoral Step Pin Insertion Rod
• 10886705002665: RIGIDFIX TIBIAL PIN INSERTION ROD
• 10886705023394: RIGIDFIX CURVE Cross Pin System Ancillary Instrumentation Tray
• 10886705023387: RIGIDFIX CURVE Cross Pin System Instrumentation Tray
• 10886705004874: Combo RIGIFIX Caddy
• 10886705004867: BTB RIGIDFIX Caddy
• 10886705004850: S T RIGIDFIX Caddy
• 10886705004843: RIGIDFIX Sterilization Tray
• 10886705003358: RIGIDFIX TIBIAL ROD 9.5mm, 20-90mm (Plus or Minus 5 Percent)
• 10886705003334: RIGIDFIX TIBIAL ROD Soft Tissue Only 7.5mm, 20-90mm (Plus or Minus 5 Percent)
• 10886705003259: RIGIDFIX TIBIAL ROD Bone Tendon Bone Only 12mm, 20-90mm (Plus or Minus 5 Percent)
• 10886705003242: RIGIDFIX TIBIAL ROD Bone Tendon Bone Only 11mm, 20-90mm (Plus or Minus 5 Percent)
• 10886705003235: RIGIDFIX TIBIAL ROD 10mm, 20-90mm (Plus or Minus 5 Percent)
• 10886705003211: RIGIDFIX TIBIAL ROD Soft Tissue Only 8mm, 20-90mm (Plus or Minus 5 Percent)
• 10886705003204: RIGIDFIX TIBIAL ROD Soft Tissue Only 7mm, 20-90mm (Plus or Minus 5 Percent)
• 10886705003174: RIGIDFIX TIBIAL BTB STEP TROCAR, SHORT
• 10886705003150: RIGIDFIX TIBIAL BTB GUIDE BLOCK
• 10886705003143: RIGIDFIX TIBIAL ST GUIDE BLOCK
• 10886705003136: RIGIDFIX Tibial Guide Frame 40-90mm (Plus or Minus 10 Percent)
• 10886705002948: RIGIDFIX ST Tibial Plateau Rod 9.5mm
• 10886705002931: RIGIDFIX ST Tibial Plateau Rod 8.5mm
• 10886705002924: RIGIDFIX ST Tibial Plateau Rod 7.5mm
• 10886705002900: RIGIDFIX Tibial Locking Ring 9.5mm
• 10886705002894: RIGIDFIX Tibial Locking Ring 8.5mm
• 10886705002887: RIGIDFIX Tibial Locking Ring 7.5mm
• 10886705002863: RIGIDFIX Tibial Trocar/Sleeve Trial
• 10886705002801: RIGIDFIX Tibial Locking Ring 10mm
• 10886705002795: RIGIDFIX Tibial Locking Ring 9mm
• 10886705002788: RIGIDFIX Tibial Locking Ring 8mm
• 10886705002771: RIGIDFIX Tibial Locking Ring 7mm
• 10886705002726: RIGIDFIX ST Tibial Plateau Rod 10mm
• 10886705002719: RIGIDFIX ST Tibial Plateau Rod 9mm
• 10886705002702: RIGIDFIX ST Tibial Plateau Rod 8mm
• 10886705002696: RIGIDFIX ST Tibial Plateau Rod 7mm
• 10886705002641: RIGIDFIX ST Tibial Plateau Guide Frame
• 10886705020164: RIGIDFIX CURVE Femoral Rod Soft Tissue Only 11 mm, 30-110mm (Plus or Minus 6 Percent)
• 10886705020157: RIGIDFIX CURVE Femoral Rod Soft Tissue Only 10.5mm, 30-110mm (Plus or Minus 6 Percent)
• 10886705020140: RIGIDFIX CURVE Femoral Rod Soft Tissue Only 10 mm, 30-110mm (Plus or Minus 6 Percent)
• 10886705020133: RIGIDFIX CURVE Femoral Rod Soft Tissue Only 9.5 mm, 30-110mm (Plus or Minus 6 Percent)
• 10886705020126: RIGIDFIX CURVE Femoral Rod Soft Tissue Only 9mm, 30-110mm (Plus or Minus 6 Percent)
• 10886705020119: RIGIDFIX CURVE Femoral Rod Soft Tissue Only 8.5mm, 30-110mm (Plus or Minus 6 Percent)
• 10886705020102: RIGIDFIX CURVE Femoral Rod Soft Tissue Only 8mm, 30-110mm (Plus or Minus 6 Percent)
• 10886705020096: RIGIDFIX CURVE Femoral Rod Soft Tissue Only 7.5mm, 30-110mm (Plus or Minus 6 Percent)
• 10886705020089: RIGIDFIX CURVE Femoral Rod Soft Tissue Only 7mm, 30-110mm (Plus or Minus 6 Percent)
• 10886705020072: RIGIDFIX CURVE Cross Pin System FEMORAL ROD, Soft Tissue Only 6.5mm, 30-110mm (Plus or Minus 6 P
• 10886705020065: RIGIDFIX CURVE Cross Pin System FEMORAL ROD, Soft Tissue Only 6mm, 30-110mm (Plus or Minus 6 Per
• 10886705019977: RIGIDFIX CURVE ST Guide Block ST Guide Block
• 10886705019960: RIGIDFIX CURVE Arc Attachment Arc Attachment