FDA.reportPublic FDA data

N/A

Primary DI
00841036284985
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
SP-2032
Catalog number
SP-2032
Published
2020-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWICORKSCREW

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWICorkscrewOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036284985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036284985008410362849858410362849850841036284985

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic knifeA hand-held manual surgical instrument designed for cutting/shaping bone during an orthopaedic surgical intervention. It is typically a heavy, one-piece instrument with a sharp, single-edged, strong cutting blade at the distal end available in various shapes and sizes, with a handle at the proximal end. It is normally made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)741-4400FXJAX-ORDERS@ZIMMERBIOMET.COM

Regulatory Flags#

DUNS number
046189866
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888233028875Pectus Blu (TM)78-880178-88012026-07-23
00888233028882Pectus Blu (TM)78-880278-88022026-07-23
00888233028899Pectus Blu (TM)78-880378-88032026-07-23
00888233086110Pectus Blu (TM)78-005378-00532026-07-23
00888233086127Pectus Blu (TM)78-005578-00552026-07-23
00888233086134Pectus Blu (TM)78-720078-72002026-07-23
00888233086141Pectus Blu (TM)78-725078-72502026-07-23
00888233086158Pectus Blu (TM)78-730078-73002026-07-23
00888233086165Pectus Blu (TM)78-735078-73502026-07-23
00888233086172Pectus Blu (TM)78-740078-74002026-07-23
00888233086189Pectus Blu (TM)78-745078-74502026-07-23
00888233086196Pectus Blu (TM)78-750078-75002026-07-23
00888233086202Pectus Blu (TM)78-755078-75502026-07-23
00888233086219Pectus Blu (TM)78-800178-80012026-07-23
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00810128536875PECTUS BLU (TM)78-850078-85002024-09-30
00888233077170PECTUS BLU (TM)78-800078-80002024-09-30
00888233077187PECTUS BLU (TM)78-808078-80802024-09-30
00888233077194PECTUS BLU (TM)78-808178-80812024-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421762MillenniumAvalign Technologies, Inc.HWI2026-06-24
08806373886355BENCOXCorentec Co., LtdHWI2026-06-09
08800017271088BENCOXCorentec Co., LtdHWI2026-05-06
00190776418878MillenniumAvalign Technologies, Inc.HWI2026-04-13
00190776416683MillenniumAvalign Technologies, Inc.HWI2026-02-16
00190776402471MillenniumAvalign Technologies, Inc.HWI2025-06-23
00810123207916Adler Instrument CompanyAdler, Inc.HWI2024-10-18
00841036284923N/ABIOMET MICROFIXATION, INCHWI2024-09-25
00822409100798N/AOrtho Development CorporationHWI2023-10-06
00190776264499AvalignAvalign Technologies, Inc.HWI2023-09-28
00190776292799MILLENNIUMAvalign Technologies, Inc.HWI2023-09-28
07898506815272QuinelatoSchobell Industrial LtdaHWI2023-07-06
14026704810991PILLINGTELEFLEX INCORPORATEDHWI2022-12-08
54026704810999PILLINGTELEFLEX INCORPORATEDHWI2022-12-08
00643169092020n/aMEDTRONIC SOFAMOR DANEK, INC.HWI2022-11-21
00842331156663Novo Surgical Inc. NOVO SURGICAL, INC.HWI2022-11-12
00673978058436Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWI2022-10-14
00673978129471Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWI2022-10-08
00673978131016Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWI2022-10-08
00190776183028MillenniumAvalign Technologies, Inc.HWI2021-11-01
00190776183035MillenniumAvalign Technologies, Inc.HWI2021-11-01
00190776183042MillenniumAvalign Technologies, Inc.HWI2021-11-01
00887868482854Cinch Modular AttachmentsBiomet Orthopedics, LLCHWI2021-03-24
00190660082734Ambler SurgicalAMBLER SURGICAL CORP.HWI2021-01-04
00889024595491Microfracture AwlZimmer, Inc.HWI2020-10-26
00889024595507Microfracture AwlZimmer, Inc.HWI2020-10-26
00889024595514Microfracture AwlZimmer, Inc.HWI2020-10-26
00889024595521Microfracture AwlZimmer, Inc.HWI2020-10-26
00889024595538Microfracture AwlZimmer, Inc.HWI2020-10-26
00889024595545Microfracture AwlZimmer, Inc.HWI2020-10-26