TensionTac
GUDID 10854629006779
TensionTac 3.0 Knotless Anchor PEEK
DUNAMIS MEDICAL, LLC
Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile| Primary Device ID | 10854629006779 |
| NIH Device Record Key | eeac0241-752f-46ff-94a0-8acb2854e1db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TensionTac |
| Version Model Number | DFX0044R |
| Company DUNS | 079471560 |
| Company Name | DUNAMIS MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 |
Customer Support Contacts
| Phone | 334-371-6280 |
| info@dunamismedical.com | |
| Phone | 334-371-6280 |
| info@dunamismedical.com | |
| Phone | 334-371-6280 |
| info@dunamismedical.com | |
| Phone | 334-371-6280 |
| info@dunamismedical.com | |
| Phone | 334-371-6280 |
| info@dunamismedical.com | |
| Phone | 334-371-6280 |
| info@dunamismedical.com | |
| Phone | 334-371-6280 |
| info@dunamismedical.com | |
| Phone | 334-371-6280 |
| info@dunamismedical.com | |
| Phone | 334-371-6280 |
| info@dunamismedical.com | |
| Phone | 334-371-6280 |
| info@dunamismedical.com | |
| Phone | 334-371-6280 |
| info@dunamismedical.com | |
| Phone | 334-371-6280 |
| info@dunamismedical.com | |
| Phone | 334-371-6280 |
| info@dunamismedical.com | |
| Phone | 334-371-6280 |
| info@dunamismedical.com | |
| Phone | 334-371-6280 |
| info@dunamismedical.com | |
| Phone | 334-371-6280 |
| info@dunamismedical.com | |
| Phone | 334-371-6280 |
| info@dunamismedical.com | |
| Phone | 334-371-6280 |
| info@dunamismedical.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854629006772 [Primary] |
| GS1 | 10854629006779 [Package] Contains: 00854629006772 Package: Box [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160996
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 | 2021-05-28 |
| Device Publish Date | 2021-05-20 |
On-Brand Devices [TensionTac]
| 10854629006779 | TensionTac 3.0 Knotless Anchor PEEK |
| 00854629006987 | TensionTac 3.5 Knotless Anchor PEEK |
Trademark Results [TensionTac]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TENSIONTAC 88793927 not registered Live/Pending |
Dunamis Medical, LLC 2020-02-12 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.