FDA.report

X-PAC

Primary DI
00850041805467
Brand
X-PAC
Company
EXPANDING INNOVATIONS, INC.
Model
EI3203
Catalog number
EI3203
Device description
Bone Screw Driver
Published
2025-09-18
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

Product Codes

CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications

CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions

SubmissionSupplement
K250602000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K250602000X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.2025-05-20KWQ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850041805467PrimaryGS10

GMDN Terms

TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
650 861 3129mmuthini@expandinginnovations.com

Regulatory Flags

DUNS number
081309444
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
00810166520003X-PACEI30572026-03-20
00810166521543X-PACEI39202025-06-05
00810166520102Expanding InnovationsEI38582025-09-24
00810166520126X-PACEI38602025-09-24
00810166520133X-PACEI38612025-09-24
00810166520140X-PACEI38622025-09-24
00810166520157X-PACEI38632025-09-24
00810166521147X-PACEI38752025-09-24
00810166521567X-PACEI39222025-09-23
00810166521697X-PACEI39252025-09-23
00850041805559X-PACEI32012025-09-19
00850041805580X-PACXP02LPSCXP02LPSC2025-09-19
00850041805610X-PACXP0113LPXP0113LP2025-09-19
00850041805665X-PACXP0215LPXP0215LP2025-09-19
00850041805689X-PACXP0411LPXP0411LP2025-09-19
00850041805696X-PACXP0413LPXP0413LP2025-09-19
00850041805474X-PACEI3204EI32042025-09-18
00850041805481X-PACEI3206EI32062025-09-18
00850041805504X-PACEI3208EI32082025-09-18
00850041805566X-PACEI3202EI32022025-09-18

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