Monkey Rings™ External Fixation System P45-223-0118

GUDID 00889795129086

BALL JOINT STRUT, SMALL

PARAGON 28, INC.

External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use

• Primary Device ID: 00889795129086
• NIH Device Record Key: 2a86f04e-24f0-466e-af97-e7026ad30e80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monkey Rings™ External Fixation System
• Version Model Number: P45-223-0118
• Catalog Number: P45-223-0118
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889795129086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212895

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-25
• Device Publish Date: 2024-04-17

On-Brand Devices [Monkey Rings™ External Fixation System]

• 00889795123961: Strut Locking Clip (Bag of 10)
• 00889795121431: Rapid Nut Allen Wrench
• 00889795120977: Case 3 Fasterner Caddy
• 00889795120960: Case 3 K-Wire Caddy
• 00889795120953: Tubular Wrench, 10mm
• 00889795120915: Case Base, Case 2 of 4
• 00889795120908: Case Dishwasher, Case 1 of 4
• 00889795118998: Spherical Washer (Pair) Bottom
• 00889795118981: Spherical Washer (Pair) TOP
• 00889795118974: Rancho Cube, Ø6.0 Centering Collar
• 00889795118967: Wire Bolt, Offset & Center hole
• 00889795118004: Anti Microbial pads
• 00889795117991: Ø6.0mm Half Pin Quick Connect (SP1306)
• 00889795117984: Ø5.0mm Half Pin Quick Connect (SP1305)
• 00889795117977: Ø4.0mm Half Pin Quick Connect (SF1304)
• 00889795117960: Ø3.2mm x 195mm Drill for HA Half Pins (SF1324)
• 00889795117953: Half Pin, Self Drilling, Ø6.0mm X 50mm, 180mm SHANK LENGTH, HA COATED (ST156180HA)
• 00889795117946: Half Pin, Self Drilling, Ø5.0mm X 50mm, 180mm SHANK LENGTH, HA COATED (ST145180HA)
• 00889795117939: Half Pin, Self Drilling, Ø4.0mm x 34mm, 120mm SHANK LENGTH, HA COATED (ST134120HA)
• 00889795117922: Wire Cutter
• 00889795117915: Tang Angled Socket Wrench, 10mm
• 00889795117908: Speed Nut
• 00889795116611: Protective Cap, 6.0
• 00889795116604: Protective Cap, 5.0
• 00889795116598: Protective Cap, 4.0
• 00889795116581: Foot Rocker Kit
• 00889795116567: Tray 1, Case 4 of 5
• 00889795116550: Case Base, Case 4 of 5
• 00889795116505: Pin Cutter
• 00889795116482: Hex Driver on T Handle
• 00889795116444: Slotted Angled Socket Wrench, 10mm
• 00889795116437: Angled Socket Wrench, 10mm
• 00889795116376: Extension Post, 5 hole
• 00889795116369: Extension Post, 2 hole
• 00889795116352: Rancho Cube, Ø5.0 Centering Collar
• 00889795116345: Rancho Cube, Ø4.0 Centering Collar
• 00889795116338: Rancho Cube, 5 hole
• 00889795116321: Rancho Cube, 4 hole
• 00889795116314: Rancho Cube, 3 hole
• 00889795116307: Rancho Cube, 2 hole
• 00889795116284: Post, 4 hole
• 00889795116277: Post, 3 hole
• 00889795116260: Post, 2 hole
• 00889795116246: Female Post, 4 hole
• 00889795116239: Female Post, 3 hole
• 00889795116222: Female Post, 2 hole
• 00889795116208: Universal Pin Clamp
• 00889795116185: Washer, 4mm
• 00889795116178: Washer, 2mm
• 00889795116161: Washer, 1mm