FDA.reportPublic FDA data

Mill Plus

Primary DI
37613327539449
Brand
Mill Plus
Company
STRYKER CORPORATION
Model
5420FNE000
Catalog number
5420-FNE-000
Device description
Fine Blade
Published
2023-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327539449PackageGS14In Commercial Distribution
07613327539448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332753944937613327539449
07613327539448076133275394487613327539448

GMDN Terms#

Term, Definition table
TermDefinition
Powered bone mill cartridgeA sterile cutting device intended to be powered by a bone mill motor to create particles of bone autografts (i.e., bone harvested from and transplanted into the same patient) for implantation during a bone regeneration or bone grafting procedure. It typically consists of a cutting disc, a plunger, and collection drawer. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+0118002533210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
196548481
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327681741N/A48110005481100052025-09-03
07613327681727N/A48110004481100042025-09-03
07613327681758N/A48110006481100062025-09-03
37613327566162Neptune075020000007502000002024-10-15
07613327504019NA5407-150-0005407-150-0002021-07-08
07613327504057NA5407-350-0005407-350-0002021-07-08
07613154495771NA62930000006293-000-0002015-09-24
07613154495801NA62970000006297-000-0002015-09-24
07613154495818NA62980000006298-000-0002015-09-24
07613154501410Electric System 6 Stryker Precision62990000006299-000-0002018-09-23
00850002250411ClariFixCFX-2002CFX-20022020-09-01
04546540517593ESSx52906012005290-601-2002016-09-24
07613327665109Sonopet iQ+55002600005500-260-0002026-10-14
07613327685114Sonopet iQ57000500005700-050-0002026-10-14
07613327665031Sonopet iQ+550026B0105500-26B-0102026-10-12
07613327665048Sonopet iQ+550026B0205500-26B-0202026-10-12
07613327665055Sonopet iQ+550026B1145500-26B-1142026-10-12
07613327665062Sonopet iQ+550026B3125500-26B-3122026-10-12
07613327687149Sonopet iQ+550026B3285500-26B-3282026-10-12
07613327662030ALPHAVENT3911-856-5473911-856-5472025-06-16

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00889024709164CANNULATED 1.5MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERZimmer, Inc.HWE2026-10-19
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10888857578241Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
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