FDA.reportPublic FDA data

Drill Bit 3.2 mm AO Shank Depth Control

Primary DI
04056481143213
Brand
Drill Bit 3.2 mm AO Shank Depth Control
Company
Brainlab SE
Model
41839-36A
Published
2022-04-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K212245000
K252562000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212245000Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw PlanningBrainlab AG2022-04-13OLO
K252562000Spine & Trauma Navigation InstrumentsBrainlab AG2025-09-12OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481143213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481143213040564811432134056481143213

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical navigation systemAn assembly of electromechanical devices used during orthopaedic computer assisted surgery (CAS) as a functional extension of the surgeon for precise procedural movement and placement (navigation) during the procedure (e.g., placement of a pedicle screw in spinal surgery). It is computer-based and typically consists of, e.g., an operator's console and a video camera used to track the instrumentation. The input to the computer is usually by means of an existing CT or MRI scan that is used as a template. The system tracks the instrumentation by reading the location points giving a three-dimensional (3-D) picture of the instrument's position/angulation. It can also be used as a training aid.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
314482980
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056481122751Sterilization Tray Standards Cranial Accessories523152020-10-21
04056481122867Sterilization Tray Frameless Biopsy System523042020-10-21
04056481122874Sterilization Tray Varioguide523032020-10-21
04056481095406STERILIZATION TRAY SPINE BASIC/ANT/UNIV52306A52306A2020-04-02
04056481122812STERILIZATION TRAY HIP REPLACEMENT52309523092020-04-02
04056481122904Sterilization Tray Trauma / Knee Arthroscopy523002020-01-31
04056481122805Sterilization Tray Hip Resurfacing52310523102019-09-27
04056481004835Em Sterilization Tray Basic Instruments18099-08A18099-08A2016-09-15
04056481002718Headband Reference Star - Connector41877-1041877-102016-09-15
04056481003715Mscope Adapter Hs/Moeller Hi-R 700/100041767-8541767-852016-09-15
04056481141363CRANIAL 4PI CT TABLE OVERLAY434302022-05-31
04056481006884ELEMENTS LEAD LOCALIZATION1.026338-022016-11-18
04056481131920Registr. Matrix Imri Ge Headholder19202C19202C2016-09-17
04056481143985Mixed Reality Spine Navigation1.02025-05-31
04056481144609ExacTrac Dynamic 2.02025-02-19
04056481144654Viewer 5.45.42024-11-05
04056481004101Target Positioner Leksell40700-20A40700-20A2016-09-15
04056481006525Em Disposable Stylet18097180972018-02-08
04056481138769Elements Trajectory Planning2.026250-02C2017-06-14
04056481141981HIP77.02020-06-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840493422275RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422282RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422299RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422305RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422312RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422329RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422336RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422343RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422350RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422367RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422374RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422381RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422121RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422138RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422145RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422152RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422169RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422176RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422183RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422190RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422206RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422213RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422220RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422237RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422244RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422251RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
M711LS7810Navigation - Vector M-SINNO Holdings, Inc.OLO2026-05-31
M711LS7820Navigation - Vector M-SINNO Holdings, Inc.OLO2026-05-31
M711LS7830Navigation - Vector M-SINNO Holdings, Inc.OLO2026-05-31