Orca Xtreme ™ Kit Knotless Button AB-6900
GUDID 00850052601225
Orca Xtreme™ Kit Knotless Button
DUNAMIS MEDICAL, LLC
Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button| Primary Device ID | 00850052601225 |
| NIH Device Record Key | ccb7f1a8-0b4c-4938-8e37-a6fbbb25287d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Orca Xtreme ™ Kit Knotless Button |
| Version Model Number | AB-6925 |
| Catalog Number | AB-6900 |
| Company DUNS | 079471560 |
| Company Name | DUNAMIS MEDICAL, LLC |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850052601225 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191319
FDA Product Code
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-22 |
| Device Publish Date | 2024-03-14 |
Devices Manufactured by DUNAMIS MEDICAL, LLC
| 00850052601072 - Hallux Guide | 2024-06-18 Hallux Guide |
| 00850052601089 - CMC Spacer | 2024-06-18 CMC Spacer |
| 00850052601096 - CMC Guide | 2024-06-18 CMC Guide |
| 00850052601157 - Threaded Driver | 2024-06-18 Threaded Driver |
| 00850052601232 - Micro Constrictor® Implantation Kit | 2024-06-18 Micro Constrictor® Implantation Kit |
| 00850052601225 - Orca Xtreme ™ Kit Knotless Button | 2024-03-22Orca Xtreme™ Kit Knotless Button |
| 00850052601225 - Orca Xtreme ™ Kit Knotless Button | 2024-03-22 Orca Xtreme™ Kit Knotless Button |
| 00850052601188 - Force DFX Suture-Xtreme™ | 2024-02-08 Force DFX Suture-Xtreme™ |
| 00850052601195 - Fixation Button-Oblong | 2024-02-08 Fixation Button-Oblong |
Trademark Results [Orca Xtreme]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORCA XTREME 97938630 not registered Live/Pending |
Dunamis Medical Technologies, LLC 2023-05-16 |
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