Orca™ Xtreme Knotless Button AB-6900
GUDID 40854629006916
Orca™ Xtreme Knotless Button
DUNAMIS MEDICAL, LLC
Orthopaedic fixation suture button| Primary Device ID | 40854629006916 |
| NIH Device Record Key | 7fbcf8f1-198c-4739-8094-27f2e89f545b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Orca™ Xtreme Knotless Button |
| Version Model Number | AB-6900 |
| 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 | 40854629006916 [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 | 2024-02-08 |
| Device Publish Date | 2024-01-31 |
Devices Manufactured by DUNAMIS MEDICAL, LLC
| 00850052601317 - Olecranon Transporter™ Repair Kit | 2025-05-07 Olecranon Transporter™ Repair Kit |
| 00850052601294 - Force DFX Suture Loop -Xtreme™ | 2025-04-18 Force DFX Suture Loop-Xtreme™ |
| 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 |
Trademark Results [Orca]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORCA 98847651 not registered Live/Pending |
ORCA 2024-11-11 |
 ORCA 98845677 not registered Live/Pending |
ORCA 2024-11-10 |
 ORCA 98713607 not registered Live/Pending |
HarbisonWalker International Holdings, Inc. 2024-08-23 |
 ORCA 98532361 not registered Live/Pending |
Orca Companies, LLC 2024-05-03 |
 ORCA 98326575 not registered Live/Pending |
Orca Innovation LLC 2023-12-21 |
 ORCA 98326562 not registered Live/Pending |
Orca Innovation LLC 2023-12-21 |
 ORCA 98183524 not registered Live/Pending |
Orca Life, LLC 2023-09-17 |
 ORCA 98117708 not registered Live/Pending |
Obray Business Ventures, LLC 2023-08-04 |
 ORCA 97897107 not registered Live/Pending |
Pride Manufacturing Company, LLC 2023-04-19 |
 ORCA 97762783 not registered Live/Pending |
Pride Manufacturing Company, LLC 2023-01-20 |
 ORCA 97750146 not registered Live/Pending |
S & F SUPPLIES, INC 2023-01-11 |
 ORCA 97656674 not registered Live/Pending |
The Department of the Navy 2022-11-01 |
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