| Primary Device ID | 00615521004712 | 
| NIH Device Record Key | b98a2955-66fb-4fe6-8e15-a1542c0f814b | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Arthrex | 
| Version Model Number | AR-6529-01 | 
| Company DUNS | 147805894 | 
| Company Name | ALLEN MEDICAL SYSTEMS, INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | false | 
| Serial Number | true | 
| Manufacturing Date | true | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Phone | +1(800)934-4404 | 
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 | 
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 | 
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 | 
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 | 
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 | 
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 | 
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 | 
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 | 
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 | 
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 | 
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 | 
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 | 
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 | 
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 | 
| complaints@arthrex.com | |
| Phone | +1(800)934-4404 | 
| complaints@arthrex.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00615521004712 [Primary] | 
| HST | Apparatus, traction, non-powered | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-05-31 | 
| Device Publish Date | 2024-05-23 | 
| 00615521039059 | HDS, Table Clamp Set, DEN | 
| 00615521021849 | HDS, Perineal Post Pad | 
| 00615521004880 | HDS, Table Clamp Set, JP | 
| 00615521004866 | HDS, Table Clamp Set, UK | 
| 00615521004842 | Stabilizer Leg, HDS | 
| 00615521004835 | HDS, Well Leg Adaptor | 
| 00615521004828 | HDS Long Well Leg Spar | 
| 00615521004804 | HDS Operative Spar Cover | 
| 00615521004781 | HDS, Table Clamps, EU | 
| 00615521004774 | HDS, Table Clamps, US | 
| 00615521004750 | HDS, Perineal Post | 
| 00615521004736 | HDS Long Operative Leg Spar | 
| 00615521004729 | Prep Table Attachment, HDS | 
| 00615521004712 | HDS, Patient Platform | 
| 00615521004699 | TENSIOMETER | 
| 00615521004682 | Sterilizable Clamp | 
| 00615521004675 | Quick Release Post | 
| 00615521004668 | Ankle Distractor | 
| 00615521004620 | Japan Clamp, Shoulder Suspension System | 
| 00615521004613 | Denyer Clamp, Shoulder Suspension System | 
| 00615521004606 | UK Clamp, Shoulder Suspension System | 
| 00615521004590 | EU Clamp, Shoulder Suspension System | 
| 00615521004583 | US Clamp, Shoulder Suspension System | 
| 00615521004569 | Weight, 2.5lb (1.1kg) | 
| 00615521004552 | Weight Hanger, 10 lbs (4.5kg), S3 | 
| 00615521004521 | Shoulder Suspension Tower | 
| 00615521004514 | Univ Head Positnr, w/out Hndls, Arthrex | 
| 00615521004507 | Clamp for JP OR Bed Clark Rails | 
| 00615521004491 | UHP Replace Strap, Beach Chair, Arthrex | 
| 00615521004460 | Reusable Security Strap | 
| 00615521004439 | Easy Lock Socket, EU | 
| 00615521004422 | Easy Lock Socket US | 
| 00615521004415 | Clamp for UK OR Bed Clark Rails | 
| 00615521004408 | Clamp for EU OR Bed Clark Rails | 
| 00615521004392 | Clamp for US OR Bed Clark Rails | 
| 00615521004385 | Intubation Pad & Plate | 
| 00615521004354 | Universal Head Positioner | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  ARTHREX  87595305  5598566 Live/Registered | Arthrex, Inc. 2017-09-04 | 
|  ARTHREX  87595302  5598565 Live/Registered | Arthrex, Inc. 2017-09-04 | 
|  ARTHREX  85078407  3911238 Live/Registered | Arthrex, Inc. 2010-07-06 | 
|  ARTHREX  74317485  1788030 Live/Registered | ARTHREX INC. 1992-09-24 | 
|  ARTHREX  74128118  not registered Dead/Abandoned | Arthrex Arthroscopy Instruments, Inc. 1991-01-04 | 
|  ARTHREX  73436631  1328327 Dead/Cancelled | Surgical Equipment Associates, Ltd. 1983-07-28 | 
|  ARTHREX  73281788  1191044 Dead/Cancelled | Gerchenson; Emile H. 1980-10-14 |