FDA.reportPublic FDA data

Accelus Navigated Reusable Instruments

Primary DI
00810045534947
Brand
Accelus Navigated Reusable Instruments
Company
Integrity Implants Inc.
Model
ASY-00734
Catalog number
ASY-00734
Device description
Nav 5.5 mm Quad Lead Tap
Published
2022-03-04
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
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212088000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212088000Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.2021-12-23OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810045534947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045534947008100455349478100455349470810045534947

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800.201.9300customerservice@integrityimplants.com

Regulatory Flags#

DUNS number
080300717
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810004722507NAASY-00181ASY-001812020-06-03
00810004722514NAASY-00182ASY-001822020-06-03
00810004722491NAASY-00180ASY-001802019-10-07
00810004722521NAASY-00267ASY-002672019-10-07
00810004722538NAASY-00268ASY-002682019-10-07
00810004722545NAASY-00269ASY-002692019-10-07
00810004722552NAASY-00270ASY-002702019-10-07
00810004722569NAASY-00183ASY-001832019-10-07
00810004722576NAASY-00184ASY-001842019-10-07
00810004722736NAASY-00272ASY-002722019-10-07
00810004722743NAASY-00273ASY-002732019-10-07
00840200409926FlareHawkFHTPWB52025-10-02
00840200410595LineSiderASY-001962025-10-02
00840200410656NACMP-03002CMP-030022025-07-17
00810045531014FlareHawkFHTPCS0026TTSFHTPCS0026TTS2022-12-08
00810045531021FlareHawkFHTPCT0026TTSFHTPCT0026TTS2022-12-08
00810045531038FlareHawkFHTPCS0030TTSFHTPCS0030TTS2022-12-08
00810045531045FlareHawkFHTPCT0030TTSFHTPCT0030TTS2022-12-08
00840200407984FlareHawkFHTGCS0023TTFHTGCS0023TT2023-10-16
00840200407991FlareHawkFHTGCT0023TTFHTGCT0023TT2023-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376632919InvictusALPHATEC SPINE, INC.OLO2026-10-20
04056481147969Spine and Trauma NavigationBrainlab SEOLO2026-10-19
00889024673403NavitrackER®Orthosoft IncOLO2026-06-26
00889024699762ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699779ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699786ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699793ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699809ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699816ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699823ROSA® ShoulderOrthosoft IncOLO2026-06-26
00887868581083ROSA® RoboticsOrthosoft IncOLO2026-02-20
00889024703186ROSA® ShoulderOrthosoft IncOLO2026-01-27
00889024674790ROSA PIN STABILIZER 60MMOrthosoft IncOLO2025-12-12
00889024674776ROSA POLYAXIAL REFERENCE SIZE 3Orthosoft IncOLO2025-12-11
00889024674783ROSA POLYAXIAL REFERENCE SIZE 6Orthosoft IncOLO2025-12-11
00889024674806ROSA STABILIZER TISSUE DEFLECTOR 60MMOrthosoft IncOLO2025-12-11
00889024687455ROSA® KneeOrthosoft IncOLO2025-11-21
07613252286578FLUOROMAPStryker Leibinger GmbH & Co. KGOLO2025-01-28
00887868557873ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557880ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557897ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557903ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557910ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558078ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558092ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558160ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558177ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558306ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575105ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575112ROSA® ShoulderOrthosoft IncOLO2024-03-06