FDA.report

HALL STYLE MICRO-SAGITTAL

Primary DI
00880304389946
Brand
HALL STYLE MICRO-SAGITTAL
Company
Biomet Orthopedics, LLC
Model
505335
Catalog number
505335
Published
2019-04-18
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

Related Records

Contact Domains

Product Codes

CodeName
HSZInstrument, surgical, orthopedic, pneumatic powered & accessory/attachment

Product Code Classifications

CodeDeviceSpecialtyClass
HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00880304389946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304389946008803043899468803043899460880304389946

GMDN Terms

TermDefinition
Sagittal surgical saw blade, single-useA sterile, flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery. This device is designed with the cutting teeth arranged in an arc at the distal end pointing directly forward. It cuts when the blade is powered in a rapid oscillating (side to side) movement. This type of blade allows a frontal cutting action to be applied within a restricted area. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags

DUNS number
129278169
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
false
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 DIBrandModelCatalogPublished
00889024706828Mini Baseplate Sizer Cannulated HandleSSI008562SSI0085622026-03-19
00889024706835Mini Baseplate Sizer 0 degree On-axis HandleSSI008561SSI0085612026-03-19
00887868551611StageOne Select4311904311902026-03-17
00887868551628StageOne Select4311914311912026-03-17
00887868551635StageOne Select4311924311922026-03-17
00887868551642StageOne Select4311934311932026-03-17
00887868551659StageOne Select4311944311942026-03-17
00887868551666StageOne Select4311954311952026-03-17
00887868551673StageOne Select4311964311962026-03-17
00887868551680StageOne Select4311974311972026-03-17
00887868551697StageOne Select4311984311982026-03-17
00887868551703STAGEONE SELECT4311994311992026-03-17
00889024706774Biomet®32-34169232-3416922026-03-12
00889024706781Biomet®32-14815332-1481532026-03-12
00889024706798Biomet®32-14815132-1481512026-03-12
00889024706804Biomet®32-34169732-3416972026-03-12
00889024706811Biomet®32-14814932-1481492026-03-12
00889024706484Vanguard®32-34702132-3470212026-02-27
00880304009615BMP CABLE CUTTER4980104980102020-05-23
00880304387676OPEN END CUTTER4980234980232020-05-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00887919964308Brasseler USAPeter Brasseler Holdings, LLCHSZ2024-11-19
00887919971733Brasseler USAPeter Brasseler Holdings, LLCHSZ2024-11-19
00887919971764Brasseler USAPeter Brasseler Holdings, LLCHSZ2024-11-19
00887919971795Brasseler USAPeter Brasseler Holdings, LLCHSZ2024-11-19
00763000714635MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2023-12-01
00763000865627MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2023-12-01
08800017288376LOSPA IS Spinal SystemCorentec Co., LtdHSZ2022-10-21
10885862090454AcudriverExactech, Inc.HSZ2022-09-19
10885862090560NAExactech, Inc.HSZ2022-09-19
00847399004338MicroAire® Microaire Surgical Instruments LLCHSZ2022-09-17
00847399004765MicroAire® Microaire Surgical Instruments LLCHSZ2022-09-01
10885862090225NAExactech, Inc.HSZ2022-07-28
10885862090232NAExactech, Inc.HSZ2022-07-28
10885862090256NAExactech, Inc.HSZ2022-07-28
10885862090263NAExactech, Inc.HSZ2022-07-28
10885862090362NAExactech, Inc.HSZ2022-07-28
10885862090379NAExactech, Inc.HSZ2022-07-28
10885862090416NAExactech, Inc.HSZ2022-07-28
10885862090423NAExactech, Inc.HSZ2022-07-28
10885862090430NAExactech, Inc.HSZ2022-07-28
10885862090485NAExactech, Inc.HSZ2022-07-28
10885862090492NAExactech, Inc.HSZ2022-07-28
10885862090508NAExactech, Inc.HSZ2022-07-28
10885862090522NAExactech, Inc.HSZ2022-07-28
10885862090539NAExactech, Inc.HSZ2022-07-28
10885862090546NAExactech, Inc.HSZ2022-07-28
00763000513443MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2022-06-30
00763000513450MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2022-06-30
00763000513832MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2022-04-22
00763000513863MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2022-04-22