Orca™ Knotless Tendon Repair AB-6200

GUDID 00854629006925

Orca™ Knotless Tendon Repair

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
Primary Device ID00854629006925
NIH Device Record Keyfc008557-304e-48e9-82cc-c7eaf80d3819
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrca™ Knotless Tendon Repair
Version Model NumberAB-6200
Catalog NumberAB-6200
Company DUNS079471560
Company NameDUNAMIS MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-454-2186
Emailinfo@dunamismedical.com
Phone877-454-2186
Emailinfo@dunamismedical.com
Phone877-454-2186
Emailinfo@dunamismedical.com
Phone877-454-2186
Emailinfo@dunamismedical.com
Phone877-454-2186
Emailinfo@dunamismedical.com
Phone877-454-2186
Emailinfo@dunamismedical.com
Phone877-454-2186
Emailinfo@dunamismedical.com
Phone877-454-2186
Emailinfo@dunamismedical.com
Phone877-454-2186
Emailinfo@dunamismedical.com
Phone877-454-2186
Emailinfo@dunamismedical.com
Phone877-454-2186
Emailinfo@dunamismedical.com
Phone877-454-2186
Emailinfo@dunamismedical.com
Phone877-454-2186
Emailinfo@dunamismedical.com
Phone877-454-2186
Emailinfo@dunamismedical.com
Phone877-454-2186
Emailinfo@dunamismedical.com
Phone877-454-2186
Emailinfo@dunamismedical.com
Phone877-454-2186
Emailinfo@dunamismedical.com
Phone877-454-2186
Emailinfo@dunamismedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100854629006925 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-08
Device Publish Date2023-07-31

Devices Manufactured by DUNAMIS MEDICAL, LLC

00850052601072 - Hallux Guide2024-06-18 Hallux Guide
00850052601089 - CMC Spacer2024-06-18 CMC Spacer
00850052601096 - CMC Guide2024-06-18 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 Button2024-03-22 Orca Xtreme™ Kit Knotless Button
00850052601188 - Force DFX Suture-Xtreme™2024-02-08 Force DFX Suture-Xtreme™
00850052601195 - Fixation Button-Oblong2024-02-08 Fixation Button-Oblong

Trademark Results [Orca]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORCA
ORCA
98532361 not registered Live/Pending
Orca Companies, LLC
2024-05-03
ORCA
ORCA
98326575 not registered Live/Pending
Orca Innovation LLC
2023-12-21
ORCA
ORCA
98326562 not registered Live/Pending
Orca Innovation LLC
2023-12-21
ORCA
ORCA
98183524 not registered Live/Pending
Orca Life, LLC
2023-09-17
ORCA
ORCA
98117708 not registered Live/Pending
Obray Business Ventures, LLC
2023-08-04
ORCA
ORCA
97897107 not registered Live/Pending
Pride Manufacturing Company, LLC
2023-04-19
ORCA
ORCA
97762783 not registered Live/Pending
Pride Manufacturing Company, LLC
2023-01-20
ORCA
ORCA
97750146 not registered Live/Pending
S & F SUPPLIES, INC
2023-01-11
ORCA
ORCA
97656674 not registered Live/Pending
The Department of the Navy
2022-11-01
ORCA
ORCA
97586923 not registered Live/Pending
Fauna Bio Incorporated
2022-09-12
ORCA
ORCA
97366857 not registered Live/Pending
Benator, Max
2022-04-16
ORCA
ORCA
97237992 not registered Live/Pending
Dunamis Medical Technologies, LLC
2022-01-25

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