FDA.report

A8 INTEGR8® Porous Pedicle Screw System

Primary DI
00850062071964
Brand
A8 INTEGR8® Porous Pedicle Screw System
Company
ALLUMIN8, INC.
Model
RST-60-0120
Catalog number
RST-60-0120
Device description
Ti Rod - Straight 6.0x120mm
Published
2026-02-27
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
true

Related Records

Contact Domains

Product Codes

CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications

CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions

SubmissionSupplement
K242827000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K242827000A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.2025-10-20NKB

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850062071964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850062071964008500620719648500620719640850062071964

GMDN Terms

TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

Device Sizes

TypeValueUnit
Length120Millimeter
Outer Diameter6Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1 (417) 689-2424info@allumin8.com

Regulatory Flags

DUNS number
121774080
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00850062071001A8 INTEGR8® Porous Pedicle Screw SystemA8-00-CAPA8-00-CAP2026-02-27
00850062071506A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0025RST-55-00252026-02-27
00850062071513A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0030RST-55-00302026-02-27
00850062071520A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0035RST-55-00352026-02-27
00850062071537A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0040RST-55-00402026-02-27
00850062071544A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0045RST-55-00452026-02-27
00850062071551A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0050RST-55-00502026-02-27
00850062071568A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0055RST-55-00552026-02-27
00850062071575A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0060RST-55-00602026-02-27
00850062071582A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0065RST-55-00652026-02-27
00850062071599A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0070RST-55-00702026-02-27
00850062071605A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0075RST-55-00752026-02-27
00850062071612A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0080RST-55-00802026-02-27
00850062071629A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0085RST-55-00852026-02-27
00850062071636A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0090RST-55-00902026-02-27
00850062071643A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0095RST-55-00952026-02-27
00850062071650A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0100RST-55-01002026-02-27
00850062071667A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0110RST-55-01102026-02-27
00850062071674A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0120RST-55-01202026-02-27
00850062071681A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0130RST-55-01302026-02-27

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Primary DIBrandCompanyProduct codePublished
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