FDA.report

A8 INTEGR8® Porous Pedicle Screw System

Primary DI
00850080774052
Brand
A8 INTEGR8® Porous Pedicle Screw System
Company
ALLUMIN8, INC.
Model
A8TP-002-0085
Catalog number
A8TP-002-0085
Device description
Tap: 8.5 mm
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

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850080774052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850080774052008500807740528500807740520850080774052

GMDN Terms

TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

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
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 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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