FDA.report

ANAX™ OCT Spinal System

Primary DI
08800037546067
Brand
ANAX™ OCT Spinal System
Company
U&I CORPORATION
Model
OS0330
Published
2021-03-04
Public version status
New
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

Product Codes

CodeName
HXBPROBE

Product Code Classifications

CodeDeviceSpecialtyClass
HXBProbeOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800037546067PrimaryGS10

GMDN Terms

TermDefinition
Orthopaedic feelerA hand-held manual surgical instrument designed to identify the position and/or shape of bone structures and/or cavities created within these structures, e.g., the angle of a drilled hole, during surgery. It is typically designed as a long, thin, shaft with a handle or handle connector at the proximal end and typically a round ball-tip at the distal end. It is typically made of high-grade stainless steel and/or synthetic material and is used by the surgeon to recognize structures and cavities through a tactile feedback. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
688811082
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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 DIBrandModelCatalogPublished
08800037576057Perfix™ Spinal SystemSN00422023-06-01
08800037567277Dyna Locking Trochanteric NailNG23702023-05-23
08800037567284Dyna Locking Trochanteric NailNG23752023-05-23
08800037567291Dyna Locking Trochanteric NailNG23802023-05-23
08800037567307Dyna Locking Trochanteric NailNG23852023-05-23
08800037567314Dyna Locking Trochanteric NailNG23902023-05-23
08800037567321Dyna Locking Trochanteric NailNG23952023-05-23
08800037567338Dyna Locking Trochanteric NailNG24002023-05-23
08800037567345Dyna Locking Trochanteric NailNG24052023-05-23
08800037567352Dyna Locking Trochanteric NailNG24102023-05-23
08800037567369Dyna Locking Trochanteric NailNG24152023-05-23
08800037567376Dyna Locking Trochanteric NailNG24202023-05-23
08800037575845Dyna Locking Trochanteric NailNG09102023-05-23
08800037575852Dyna Locking Trochanteric NailNG09112023-05-23
08800037575869Dyna Locking Trochanteric NailNG09122023-05-23
08800037575876Dyna Locking Trochanteric NailNG09132023-05-23
08800037575883Dyna Locking Trochanteric NailNG09142023-05-23
08800037575890Dyna Locking Trochanteric NailNG09202023-05-23
08800037575906Dyna Locking Trochanteric NailNG09212023-05-23
08800037575913Dyna Locking Trochanteric NailNG09222023-05-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00199150069675Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXB2026-03-20
10705034577449N/AMedos International SàrlHXB2026-03-05
10889981443436SpecialsSeaspine Orthopedics CorporationHXB2026-03-03
10888857578197Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578203Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578630Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578647Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578654Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578661Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578678Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578685Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578692Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578708Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
03662663131551Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131568Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131575Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131582Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131599Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131605Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131612Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
00860014213458Introducer ProbeTETROUS, INC.HXB2026-02-10
00860014213472Pusher ProbeTETROUS, INC.HXB2026-02-10
00860014213496Introducer Probe - SJTETROUS, INC.HXB2026-02-10
00810158218833PRINCETONPrinceton Medical Group, Inc.HXB2026-02-05
00810158218840PRINCETONPrinceton Medical Group, Inc.HXB2026-02-05
00810158218857PRINCETONPrinceton Medical Group, Inc.HXB2026-02-05
00810158218864PRINCETONPrinceton Medical Group, Inc.HXB2026-02-05
10889981441531SpecialsSeaspine Orthopedics CorporationHXB2026-01-30
00840180544013General InstrumentsALPHATEC SPINE, INC.HXB2026-01-29
00840180545188General InstrumentsALPHATEC SPINE, INC.HXB2026-01-29