FDA.reportPublic FDA data

A8 INTEGR8® Porous Pedicle Screw System

Primary DI
00850080772843
Brand
A8 INTEGR8® Porous Pedicle Screw System
Company
ALLUMIN8, INC.
Model
A8NS-002-0002
Catalog number
A8NS-002-0002
Device description
Inserter
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850080772843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850080772843008500807728438500807728430850080772843

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (417) 689-2424info@allumin8.com

Regulatory Flags#

DUNS number
121774080
Device count
1
DM exempt
false
Premarket exempt
true
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 DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506090998ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091001ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091018ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00841523181360Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181681Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181698Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181704Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
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00841523181742Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181759Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181766Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181773Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181780Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181797Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181803Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181810Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181827Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181834Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181841Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181858Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181865Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26