FDA.reportPublic FDA data

Brickyard Stand-Alone ALIF

Primary DI
00843210188782
Brand
Brickyard Stand-Alone ALIF
Company
Altus Spine, LLC
Model
1030-4009
Device description
Paddle Distractor, Small Hudson, 9mm
Published
2024-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211837000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211837000Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC2022-04-19OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843210188782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843210188782008432101887828432101887820843210188782

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical distractor, internalA hand-held manual surgical instrument designed to invasively distract (force apart) two bone surfaces to enable a surgical procedure. It typically aids in fracture reduction by helping to temporarily stabilize bones prior to definitive surgical fixation. It typically consists of a central threaded spindle, a static endpiece and a sliding carriage that can be adjusted using spindle nuts to/from the endpiece to widen or shorten the gap; it facilitates the attachment of orthopaedic bone pins (Schanz screws) screwed into the bones to be distracted. It is typically used for multiple injuries when it is advantageous to perform procedures on a standard operating table. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
610-355-4156QARA@Altus-Spine.com

Regulatory Flags#

DUNS number
078331322
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843210180731Brickyard Stand-Alone ALIF1030-04132024-08-29
00843210176611Indy Standalone1030-04132024-07-24
00843210133478Imola-Silverstone600-31092018-10-06
00843210134161Imola-Silverstone790-00022018-10-06
00843210176567Sochi300-09012025-03-13
00843210167381SochiA16-30-25352024-10-03
00843210167398SochiA16-30-31412024-10-03
00843210167404SochiA16-30-38482024-10-03
B41710010011Monza Cervical Plate System100-10012016-10-28
B41711040121Monza Cervical Plate System110-40122016-10-28
B41711040141Monza Cervical Plate System110-40142016-10-28
B41711040161Monza Cervical Plate System110-40162016-10-28
B41711040181Monza Cervical Plate System110-40182016-10-28
B41711043121Monza Cervical Plate System110-43122016-10-28
B41711043141Monza Cervical Plate System110-43142016-10-28
B41711043161Monza Cervical Plate System110-43162016-10-28
B41711043181Monza Cervical Plate System110-43182016-10-28
B41711140121Fuji Cervical Plate System111-40122017-08-22
B41711140131Fuji Cervical Plate System111-40132017-08-22
B41711140141Fuji Cervical Plate System111-40142017-08-22

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Primary DI, Brand, Company table
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00841523185030Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185047Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185054Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185061Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185078Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
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00841523185139Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
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00841523185160Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185177Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185382Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
B382SD484620Surgical DirectSurgical Direct, Inc.LXH2026-08-07
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B382SD480033220Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
00190776407391MillenniumAvalign Technologies, Inc.LXH2026-07-31
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00840606191630Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
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00840606191692Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191708Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31