FDA.reportPublic FDA data

Mallet

Primary DI
00816950029479
Brand
Mallet
Company
Osteocentric Technologies, Inc.
Model
317-0016
Catalog number
317-0016
Device description
Mallet
Published
2021-05-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXLMallet
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXLMalletGeneral, Plastic Surgery1
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210247000OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma2021-04-30JDO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816950029479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816950029479008169500294798169500294790816950029479

GMDN Terms#

Term, Definition table
TermDefinition
Surgical malletA hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-969-0639quality@osteocentric.com

Regulatory Flags#

DUNS number
089645059
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008100978037493.0mm GUIDE WIRE 355mm202-80600202-806002026-06-02
00810118210198Torque Wrench701-0019701-00192023-10-31
00810118210259.050 Driver, Short701-0025701-00252023-10-31
00810118210266.050 Driver, Long701-0026701-00262023-10-31
00810118210273.050 Driver, Latch701-0027701-00272023-10-31
00810118210280Thumb Knob701-0029701-00292023-10-31
00810118210327Latch Driver, 300 Series701-0033701-00332023-10-31
00810118210334Square Driver, 300 Series701-0034701-00342023-10-31
00810118210341Latch Driver, 400 Series701-0035701-00352023-10-31
00810118210358Square Driver, 400 Series701-0036701-00362023-10-31
00810118210365Ratchet Adapter701-0037701-00372023-10-31
008101182100063.7mm Tap701-0013701-00132023-10-30
008101182100134.2mm Tap701-0014701-00142023-10-30
008101182100205.5mm Tap701-0015701-00152023-10-30
00810118210129Drill Extender701-0009701-00092023-10-30
008101182101673.7mm Parallel Pin701-0016701-00162023-10-30
008101182101744.2mm Parallel Pin701-0017701-00172023-10-30
008101182101815.5mm Parallel Pin701-0018701-00182023-10-30
00810097803527NAV 3.5mm DRILL104-0003104-00032026-03-26
00810097803534NAV TAPERED PROBE104-0005104-00052026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462912995evonosevonos GmbH & Co. KGHXL2026-08-19
04054462913008evonosevonos GmbH & Co. KGHXL2026-08-19
04054462913015evonosevonos GmbH & Co. KGHXL2026-08-19
04054462905553evonosevonos GmbH & Co. KGHXL2026-08-18
04054462907618evonosevonos GmbH & Co. KGHXL2026-08-18
04054462907625evonosevonos GmbH & Co. KGHXL2026-08-18
B382SD5422310000Surgical DirectSurgical Direct, Inc.HXL2026-08-03
B382SD914542230Surgical DirectSurgical Direct, Inc.HXL2026-07-27
B382SD9145561200Surgical DirectSurgical Direct, Inc.HXL2026-07-27
B382SD9145571030Surgical DirectSurgical Direct, Inc.HXL2026-07-27
B382SD914569410000Surgical DirectSurgical Direct, Inc.HXL2026-07-27
07613327616859HOFFMANN LRFStryker GmbHKTT2026-07-23
07613327616880HOFFMANN LRFStryker GmbHKTT2026-07-23
07613327616835HOFFMANN LRFStryker GmbHKTT2026-07-21
07613327616866HOFFMANN LRFStryker GmbHKTT2026-07-21
00889795154620Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154637Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154644Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154651Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
10888867544571Arthrex®ARTHREX, INC.KTT2026-03-13
00810135963657ImpactNVision Biomedical Technologies, Inc.HXL2025-09-24
10886982346872MAXFRAMESynthes GmbHKTT2025-01-29
10886982338778MAXFRAMESYNTHES (U.S.A.) LPKTT2024-02-05
10886982343710MAXFRAMESynthes GmbHKTT2024-01-04
10886982343727MAXFRAMESynthes GmbHKTT2024-01-04
10886982343734MAXFRAMESynthes GmbHKTT2024-01-04
00841732162754GENERIC Surgical InstrumentsCTL Medical CorporationHXL2023-09-27
B382SD9145561000Surgical DirectSurgical Direct, Inc.HXL2022-12-02
B382SD91456921000Surgical DirectSurgical Direct, Inc.HXL2022-12-02
B382SD9145561030Surgical DirectSurgical Direct, Inc.HXL2022-11-30