FDA.reportPublic FDA data

Titan™

Primary DI
10381780247432
Brand
Titan™
Company
Ascension Orthopedics, Inc.
Model
SET188A001
Catalog number
SET188-A001
Device description
Total Shoulder System Head Extractor
Published
2017-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780247432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178024743210381780247432

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made orthopaedic/craniofacial surgical guideA custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
942377524
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780240204Cadence™102030222016-08-24
10381780240211Cadence™10203023102030232016-08-24
10381780240228Cadence™10203024102030242016-08-24
10381780240235Cadence™102030252016-08-24
10381780240242Cadence™102030262016-08-24
10381780240754Cadence™10204202102042022016-08-24
10381780245612Titan™IMC096004301IMC-0960-043-012017-08-30
10381780246374Integra®OSG20000OSG-200-002017-08-30
10381780246381Integra®OSG20010POSG-200-10P2017-08-30
10381780246398Integra®OSG20010PVOSG-200-10PV2017-08-30
10381780246404Integra®OSG20020POSG-200-20P2017-08-30
10381780246411Integra®OSG20020PVOSG-200-20PV2017-08-30
10381780246428Integra®OSG20030POSG-200-30P2017-08-30
10381780246435Integra®OSG20030PVOSG-200-30PV2017-09-05
10381780246442Integra®OSG20040POSG-200-40P2017-09-05
10381780246459Integra®OSG20040PVOSG-200-40PV2017-08-30
10381780246466Integra®OSG35001OSG-350-012017-08-30
10381780246473Integra®OSG44200OSG-442-002017-09-05
10381780246480First Choice® DRUJ SystemOSG60000OSG-600-002017-09-05
10381780246497First Choice® DRUJ SystemOSG60001OSG-600-012017-09-05

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10840642149838Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
10840642149845Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
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00824846013082Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-19
00850078396440SYNQ Single-Use Instrument System(1066)Eca Medical InstrumentsLXH2026-10-19
00889024715295Persona Extended V/V Guide Assembly (MFS)Zimmer, Inc.LXH2026-10-19
08809986489807LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-19
00810111228671Cut GuideTreace Medical Concepts, Inc.LXH2026-10-16
00810161900305EARP, TRIAL 22X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900312EARP, TRIAL 22X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900329EARP, TRIAL 22X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900336EARP, TRIAL 22X35X14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901418EARP TRIAL 22x40x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
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