FDA.report

A8 INTEGR8® Porous Pedicle Screw System

Primary DI
00850080772973
Brand
A8 INTEGR8® Porous Pedicle Screw System
Company
ALLUMIN8, INC.
Model
A8NS-002-0019
Catalog number
A8NS-002-0019
Device description
Torque Handle, 12 Nm
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
00850080772973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850080772973008500807729738500807729730850080772973

GMDN Terms

TermDefinition
Surgical instrument handle, torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. 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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