FDA.report

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

Related Records

Contact Domains

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780247432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178024743210381780247432

GMDN Terms

TermDefinition
Custom-made orthopaedic surgical guide, non-sterileA non-sterile, 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 made of synthetic polymer materials and 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 intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

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10381780355946Titan™IMP-0926-030-02AIMP-0926-030-02A2018-10-04
10381780355953Titan™IMP-0926-030-03AIMP-0926-030-03A2018-10-04
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M268TIWEDGEINSTP1TiWedgeTMTIWEDGEINSTP2016-08-15
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10381780123033CAPTURE™ High Torque Screw SystemCSS500000630WTCSS500000630WT2017-10-09
10381780123040CAPTURE™ High Torque Screw SystemCSS500000640WTCSS500000640WT2017-10-09
10381780123057CAPTURE™ High Torque Screw SystemCSS500000650WTCSS500000650WT2017-10-09
10381780123064CAPTURE™ High Torque Screw SystemCSS500000670WTCSS500000670WT2017-10-09
M26922286111Integra®222861122286112017-08-30
M26922378111Integra®223781122378112017-08-30
M269AI11031CAPTURE™AI-1103AI11032017-08-30
M269AI31011CAPTURE™AI-3101AI31012017-08-30
M269AI32011CAPTURE™AI-3201AI32012017-08-30
M269AI32021CAPTURE™AI-3202AI32022017-08-30

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