FDA.reportPublic FDA data

TITAN™

Primary DI
10381780258353
Brand
TITAN™
Company
Ascension Orthopedics, Inc.
Model
PN-0926-001
Device description
The Fin-Lock Punch is used to impact the bone for proper fit of the glenoid. It can also be used to further pressurize the cement.
Published
2016-05-19
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
HXOPUSHER, SOCKET

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXOPusher, SocketOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780258353PrimaryGS10
M269PN09260011SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178025835310381780258353

GMDN Terms#

Term, Definition table
TermDefinition
Bone cutterA strongly constructed, hand-held, surgical instrument designed to separate a bone into two parts through a cutting action. It typically consists of an instrument having one or two sharp robust blades that close over the bone and cut it. It is available in various designs: 1) a pliers-like design with elongated blades, or 2) twin angled blades attached to strong, sprung (self-opening), pivoted or multi-pivoted handles; that, when squeezed together, close the blades so that they cut entirely through the bone. Also known as bone shears, it is mainly used in orthopaedic surgical procedures and oral surgery. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780240310Cadence™102031932016-08-24
10381780245513BioMotion® Cannulated 1st MPJ Hemi SystemHM 3010HM 30102017-09-05
10381780245629Titan™IP0920055001IMP-0920-055-0012017-09-05
10381780245636Titan™IP0920064001IMP-0920-064-0012017-09-05
10381780245643Titan™IP0920079501IMP-0920-0795-012017-09-05
10381780245650Titan™IMP096006401IMP-0960-064-012017-09-05
10381780245667Titan™IMP096006601IMP-0960-066-012017-09-05
10381780245674Titan™IMP096007101IMP-0960-071-012017-09-05
10381780245681Ascension®IMP10000DIMP-100-00D2017-09-05
10381780245698Ascension®IMP10000PIMP-100-00P2017-09-05
10381780245704Integra®IMP20000DIMP-200-00D2017-09-05
10381780245711Integra®IMP20000PIMP-200-00P2017-09-05
10381780245728Integra®IMP30000IMP-300-002017-09-05
10381780245735Integra®IMP35000IMP-350-002017-09-05
10381780245759NuGrip® CMC Implant SystemIMP44200IMP-442-002017-09-05
10381780245766First Choice® DRUJ SystemIMP60000IMP-600-002017-09-05
10381780245780Movement®IMP-890-00MTIMP-890-00MT2017-09-05
10381780245797Movement®IMP-890-00PPIMP-890-00PP2017-09-05
10381780245803Integra®IMP90001IMP-900-012017-09-05
10381780245988Integra®MAL092008501MAL-0920-085-012017-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011453537Remedy Poly+Plus Acetabular CupOSTEOREMEDIES, LLCHXO2026-06-01
108500705004914.0mm Dual Obturator CURVAFIX, INC.HXO2025-10-22
04719878788106“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)Paonan Biotech Co.,Ltd.HXO2025-10-15
04262494460739N/ADoppkon GmbH & Co. KGHXO2025-09-10
04262494460746N/ADoppkon GmbH & Co. KGHXO2025-09-10
04262494460753N/ADoppkon GmbH & Co. KGHXO2025-09-10
04052536081417uCentumUlrich GmbH & Co. KGHXO2025-07-30
10810128461310Hip, Curved Knot PusherT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXO2025-04-29
08800089448739Surgical InstrumentJeil Medical CorporationHXO2024-11-14
00887868582134Affixus®Zimmer, Inc.HXO2024-10-17
00887868582325Affixus®Zimmer, Inc.HXO2024-10-17
08800247360118ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.HXO2024-04-26
04719878786768“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)Paonan Biotech Co.,Ltd.HXO2024-04-15
00613994594891Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXO2023-07-27
08809763500411MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763500510MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763500527MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
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08809763501395MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501425MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501432MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763505317MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763500176MEGA PLUS SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-14
08809763500183MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-14
08809763501333MEGA PLUS SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-14
08809763505188MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-14