FDA.reportPublic FDA data

Altus Spine HA Pedicle Screw System

Primary DI
00843210157719
Brand
Altus Spine HA Pedicle Screw System
Company
Altus Spine, LLC
Model
822-8535HA
Device description
Cannulated Polyaxial Pedicle Screw, HA Coated.
Published
2023-04-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200922000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200922000Altus Spine HA Pedicle Screw SystemAltus Partners, LLC2021-01-26NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843210157719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843210157719008432101577198432101577190843210157719

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078331322
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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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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00197157059590ZAVATION RODZavation LLCNKB2026-06-04
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00197157059637ZAVATION RODZavation LLCNKB2026-06-04
00197157059644ZAVATION RODZavation LLCNKB2026-06-04
00197157059651ZAVATION RODZavation LLCNKB2026-06-04
00197157059668ZAVATION RODZavation LLCNKB2026-06-04
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