Monkey Rings™ External Fixation System P45-233-1000
GUDID 00889795128409
MODULAR BALL JOINT
PARAGON 28, INC.
External orthopaedic fixation system, single-use| Primary Device ID | 00889795128409 |
| NIH Device Record Key | 9ebe881a-39b6-459c-bd42-e126e020932a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Monkey Rings™ External Fixation System |
| Version Model Number | P45-233-1000 |
| Catalog Number | P45-233-1000 |
| Company DUNS | 042961576 |
| Company Name | PARAGON 28, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | 00889795128409 [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 | true |
| Device Is Sterile | false |
[00889795128409]
Moist Heat or Steam Sterilization
[00889795128409]
Moist Heat or Steam Sterilization
[00889795128409]
Moist Heat or Steam Sterilization
[00889795128409]
Moist Heat or Steam Sterilization
[00889795128409]
Moist Heat or Steam Sterilization
[00889795128409]
Moist Heat or Steam Sterilization
[00889795128409]
Moist Heat or Steam Sterilization
[00889795128409]
Moist Heat or Steam Sterilization
[00889795128409]
Moist Heat or Steam Sterilization
[00889795128409]
Moist Heat or Steam Sterilization
[00889795128409]
Moist Heat or Steam Sterilization
[00889795128409]
Moist Heat or Steam Sterilization
[00889795128409]
Moist Heat or Steam Sterilization
[00889795128409]
Moist Heat or Steam Sterilization
[00889795128409]
Moist Heat or Steam Sterilization
[00889795128409]
Moist Heat or Steam Sterilization
[00889795128409]
Moist Heat or Steam Sterilization
[00889795128409]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-02 |
| Device Publish Date | 2023-07-25 |
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 |
Trademark Results [Monkey Rings]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MONKEY RINGS 97273969 not registered Live/Pending |
Paragon 28, Inc. 2022-02-18 |
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