Orca Xtreme ™ Kit Knotless Button AB-6900
GUDID 00850052601225
Orca Xtreme™ Kit Knotless Button
DUNAMIS MEDICAL, LLC
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
| 00850052601256 - Micro Constrictor ®X Repair Kit | 2024-09-27 Micro Constrictor ® X Repair Kit |
| 00850052601263 - Constrictor® Mini 2.0 Syndesmosis Repair Kit | 2024-09-27 Constrictor® Mini 2.0 Syndesmosis Repair Kit |
| 00850052601270 - Constrictor® 2.0 Syndesmosis Repair Kit | 2024-09-27 Constrictor® 2.0Syndesmosis Repair Kit |
| 00854629006789 - Constrictor® Mini Syndesmosis Repair Kit | 2024-09-27 Constrictor® Mini Syndesmosis Repair Kit |
| 00850052601249 - Orca™ Implantation Kit | 2024-06-28 Orca™ Implantation Kit |
| 00850052601072 - Hallux Guide | 2024-06-18 Hallux Guide |
| 00850052601089 - CMC Spacer | 2024-06-18 CMC Spacer |
| 00850052601096 - CMC Guide | 2024-06-18 CMC Guide |
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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