FDA.reportPublic FDA data

ARCADIUS XP C

Primary DI
04046955214648
Brand
ARCADIUS XP C
Company
AESCULAP IMPLANT SYSTEMS, LLC
Model
ME516
Catalog number
ME516
Device description
ARCADIUS XP C TRIAL./INSERTION TRAY LID
Published
2024-05-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955214648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955214648040469552146484046955214648

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)229-3002setworld_orders@aesculap.com
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
622600992
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
04046955171460AESCULAPME174RME174R2020-05-08
04038653399277SPECTRUMFG331TFG331T2017-01-20
04038653399284SPECTRUMFG333TFG333T2017-01-20
04038653399291SPECTRUMFG335TFG335T2017-01-20
04038653399307SPECTRUMFG337TFG337T2017-01-20
04038653399314SPECTRUMFG338TFG338T2017-01-20
04038653399321SPECTRUMFG339TFG339T2017-01-13
04038653399338SPECTRUMFG340TFG340T2017-01-13
04038653399345SPECTRUMFG341TFG341T2017-01-20
04038653399352SPECTRUMFG343TFG343T2017-01-20
04038653399369SPECTRUMFG345TFG345T2017-01-20
04038653399376SPECTRUMFG347TFG347T2017-01-20
04038653399383SPECTRUMFG349TFG349T2017-01-20
04038653399390SPECTRUMFG351TFG351T2017-01-20
04038653399406SPECTRUMFG353TFG353T2017-01-13
04038653399413SPECTRUMFG355TFG355T2017-01-20
04038653399420SPECTRUMFG356TFG356T2017-01-20
04038653399437SPECTRUMFG358TFG358T2017-01-20
04038653399444SPECTRUMFG359TFG359T2017-01-20
04038653399451SPECTRUMFG876TFG876T2017-01-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449010134Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035489Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035496Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035502Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035519Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035526Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00889024701670Identity® Shoulder SystemZimmer, Inc.FSM2026-06-09
04251047924804Sterilizing CaseA1 Medical GmbHFSM2026-06-09
04251047926389Sterilization Tray with LidA1 Medical GmbHFSM2026-06-09
04251047930386Double-level Sterilization TrayA1 Medical GmbHFSM2026-06-09
00810055257874Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257881Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257898Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257904Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257911Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257928Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257935Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257942Surgical DesignSurgical Design, Inc.FSM2026-06-06
00857915007750Endo ECTR TrayA.M. SURGICAL, INC.FSM2026-06-04
10705037042999STERRAD™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FSM2026-06-03
07613327605716PANGEAStryker GmbHFSM2026-06-02
07613327623260MakoMAKO SURGICAL CORP.FSM2026-05-29
08435389830207STOP & GUIDE® BOXBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
08435389830962DRILL HOLDER FOR EXTRA SHORT DRILLSBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
07630055307736ACE Acetabular Reamer Tray - Instrument TrayIncipio Devices SAFSM2026-04-30
07613327652765TPXSTRYKER CORPORATIONFSM2026-03-25
07613327631852RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631869RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631876RPSSTRYKER CORPORATIONFSM2025-10-01
07613327681741N/ASTRYKER CORPORATIONFSM2025-09-03