FDA.reportPublic FDA data

ACUMED

Primary DI
10806378085604
Brand
ACUMED
Company
Acumed LLC
Model
TR-0002
Device description
Total Radial Head Tray Lid
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041858000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041858000ACUMED ANATOMIC RADIAL HEAD SYSTEMAcumed, LLC2004-10-05KWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10806378085604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080637808560410806378085604

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)627-9957businessservices@acumed.net

Regulatory Flags#

DUNS number
196884852
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10806378067341ACUMEDFX-4000-S2015-10-24
10806378067372ACUMEDFX-4001-S2015-10-24
10806378067426ACUMEDFX-4004-S2015-10-24
10806378067594ACUMEDFX-4054-S2015-10-24
10806378040368ACUMED80-01802015-10-24
10806378099182ACUMED4014-0600-S2023-01-08
10806378116094ACUMED80-39662023-01-08
10806378116131ACUMED4014-0705-S2023-01-08
10806378116148ACUMED4014-0710-S2023-01-08
10806378116155ACUMED4014-0715-S2023-01-08
10806378099175ACUMED4014-06002024-12-18
10806378116971ACUMED4014-07052024-12-18
10806378116988ACUMED4014-07102024-12-18
10806378116995ACUMED4014-07152024-12-18
10806378105296ACUMED80-34522020-03-22
10806378111976ACUMED80-36582019-08-12
10806378124273ACUMED80-42452025-12-08
10806378124280ACUMED80-43232025-12-08
10806378124297ACUMED80-43222025-12-08
10806378124310ACUMED7006-3401N2025-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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ESAM1380200003041STOMA®Storz am Mark GmbHFSM2026-07-30
ESAM1380210003041STOMA®Storz am Mark GmbHFSM2026-07-30
ESAM1387030003041STOMA®Storz am Mark GmbHFSM2026-07-30
03700569678968Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-28
10889950157623Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-07-28
00190376768748Segmental Plating SystemALPHATEC SPINE, INC.FSM2026-07-27
00810017915118Saber-C Instrument CaseELEVATION SPINE, INC.FSM2026-07-27
03700569674304Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674311Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674373Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674380Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674397Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674403Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674410Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674427Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674441Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674458Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674465Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569680145Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569680152Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569680169Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569680176Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
00190776422011MillenniumAvalign Technologies, Inc.FSM2026-07-24
00840536823717VerteGlide Spinal Growth Guidance SystemORTHOPEDIATRICS CORP.FSM2026-07-24
00840536823724VerteGlide Spinal Growth Guidance SystemORTHOPEDIATRICS CORP.FSM2026-07-24
07640221370846SCALASpineArt SAFSM2026-07-24
07640221370853SCALASpineArt SAFSM2026-07-24
07640221370860SCALASpineArt SAFSM2026-07-24
00190776421991MillenniumAvalign Technologies, Inc.FSM2026-07-23