FDA.reportPublic FDA data

NA

Primary DI
H679532067S0
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
532.067S
Catalog number
532067S
Device description
SAW BLADE 27MM WIDTH 50MM/0.6MM CUT THICKNESS-STER
Published
2016-12-31
Public version status
Update
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
HSOSAW

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSOSawGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982241054PrimaryGS10
H679532067S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698224105410886982241054

GMDN Terms#

Term, Definition table
TermDefinition
Surgical saw blade, sagittal, reusableA 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; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at the distal end to cut in a rapid sagittal (side to side) motion; it may in addition cut in an oscillating motion. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
832637081
Device count
1
DM exempt
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034718040NA03.620.219036202192018-10-29
10705034767802VentroFix304.8323048322016-12-31
10705034775418NA389.2963892962016-12-31
10705034775425NA389.2973892972016-12-31
10705034775432NA389.2983892982016-12-31
10705034775449NA389.2993892992016-12-31
10705034798455NA690.0386900382016-12-31
10887587039893NA338.7613387612016-12-31
10886982338778MAXFRAME1100022-011100022012024-02-05
10886982338570MAXFRAME1100011-011100011012022-04-26
10886982338587MAXFRAME1100010-011100010012022-04-26
10886982338594MAXFRAME1100012-011100012012022-04-26
10886982338600MAXFRAME1100007-011100007012022-04-26
10886982237217NA510.1615101612019-02-21
10887587039305NA329.37329372016-12-31
10705034741161NA04.616.135046161352015-09-14
10705034741178NA04.616.140046161402015-09-14
10705034741260NA04.616.185046161852015-09-14
10705034741284NA04.616.195046161952015-09-14
10886982027795NA02.007.000S02007000S2015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810189450783Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450790Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450806Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450813Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450820Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450837Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450844Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450851Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450868Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450875Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450882Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450899Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450905Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450912Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450929Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450936Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450943Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450950Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450967Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450974Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450981Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189451087Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810055254040Surgical DesignSurgical Design, Inc.HSO2026-04-21
00889797112666N/AWRIGHT MEDICAL TECHNOLOGY, INC.HSO2025-08-26
00889797112673N/AWRIGHT MEDICAL TECHNOLOGY, INC.HSO2025-08-26
00889797112680N/AWRIGHT MEDICAL TECHNOLOGY, INC.HSO2025-08-26
00889797112697N/AWRIGHT MEDICAL TECHNOLOGY, INC.HSO2025-08-26
00889797112703N/AWRIGHT MEDICAL TECHNOLOGY, INC.HSO2025-08-26
00887482036730Symmetry SatterleeASPEN SURGICAL PRODUCTS, INC.HSO2024-08-12
G586N8813340Novo SurgicalNOVO SURGICAL, INC.HSO2023-12-18