FDA.reportPublic FDA data

Microfracture Awl

Primary DI
00889024595545
Brand
Microfracture Awl
Company
Zimmer, Inc.
Model
82-0175-081-55
Catalog number
82-0175-081-55
Published
2020-10-26
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
00889024595545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024595545008890245955458890245955450889024595545

GMDN Terms#

Term, Definition table
TermDefinition
Bone awlA spike-like, orthopaedic, surgical instrument that is used to bore holes in bone. It is typically designed as a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end. It is manually-operated by the surgeon who rotates the point back and forth on the bone whilst exerting pressure onto the handle. This operation will penetrate the hard outer bone and create a passage into, e.g., a medullary canal. It is typically made of high-grade stainless steel, titanium (Ti) and a synthetic material for the handle (e.g., Tufnol). This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1 (800) 343-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024701670Identity® Shoulder System1200046571200046572026-06-09
00889024707382Persona Tensor Sizer Arm – LongSSI008513SSI0085132026-05-29
00889024707399Persona Tensor Sizer Arm – StdSSI008567SSI0085672026-05-29
00889024707405Persona Tensor Sizer BodySSI008566SSI0085662026-05-29
00889024081024XtraFix® Large External Fixation System00-5207-024-3000-5207-024-302016-08-09
00889024081055XtraFix® Large External Fixation System00-5207-032-3000-5207-032-302016-07-27
00889024081062XtraFix® Large External Fixation System00-5207-040-1000-5207-040-102016-07-28
00889024081079XtraFix® Large External Fixation System00-5207-040-7000-5207-040-702016-07-28
00889024081086XtraFix® Large External Fixation System00-5207-045-1000-5207-045-102016-07-28
00889024081093XtraFix® Large External Fixation System00-5210-009-0100-5210-009-012016-09-28
00889024081109XtraFix® Large External Fixation System00-5210-009-0200-5210-009-022016-09-28
00889024081147XtraFix® Large External Fixation System00-5210-019-0100-5210-019-012016-09-28
00889024081154XtraFix® Large External Fixation System00-5210-029-0100-5210-029-012016-09-28
00889024081178XtraFix® Large External Fixation System00-5210-040-0000-5210-040-002016-09-28
00889024081185XtraFix® Large External Fixation System00-5210-040-0100-5210-040-012016-09-28
00889024081192XtraFix® Large External Fixation System00-5210-040-0200-5210-040-022016-09-28
00889024081208XtraFix® Large External Fixation System00-5210-040-0300-5210-040-032016-09-28
00889024081215XtraFix® Large External Fixation System00-5210-040-0400-5210-040-042016-09-28
00889024081239XtraFix® Large External Fixation System00-5210-040-0600-5210-040-062016-09-28
00889024081253XtraFix® Large External Fixation System00-5210-050-0100-5210-050-012016-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00841036284985N/ABIOMET MICROFIXATION, INCHWI2020-06-30
00888233013789N/ABIOMET MICROFIXATION, INCHWI2020-06-16