FDA.report

X-PAC

Primary DI
00810166520003
Company
EXPANDING INNOVATIONS, INC.
Model
EI3057
Device description
Slap Hammer
Published
2026-03-20
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

Regulatory Flags

DUNS number
081309444
Device count
1
DM exempt
false
Premarket exempt
true
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00810166520003PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00810166520003PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
LXHOrthopedic Manual Surgical Instrument1Orthopedic888.4540NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Orthopaedic implant impactor, reusableA non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). This is a reusable device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
650 861 3129mmuthini@expandinginnovations.com

Other Devices From This Company

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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
00850041805467X-PACEI3203EI32032025-09-18
00850041805474X-PACEI3204EI32042025-09-18
00850041805481X-PACEI3206EI32062025-09-18
00850041805504X-PACEI3208EI32082025-09-18
00850041805566X-PACEI3202EI32022025-09-18

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