FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331189463
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
N8816-46
Catalog number
N8816-46
Device description
"charriere bone saw, stainless steel frame, w/ 2 blades, complete, 14"" (35.5 cm)"
Published
2022-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00842331189463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331189463008423311894638423311894630842331189463

GMDN Terms#

Term, Definition table
TermDefinition
Manual surgical saw, rigidA hand-held manual surgical instrument typically used in orthopaedic surgery for cutting bone or other body tissue through a sawing action performed by the user. It typically consists of a metal frame with an attached handle that firmly holds an exchangeable blade usually with the cutting teeth set in a straight line; or it may have an integral blade as part of the design which can have a straight or curved cutting edge. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1877-860-6686info@novosurgical.com

Regulatory Flags#

DUNS number
033029433
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
G586N6863510Novo SurgicalN6863-51N6863-512023-12-18
G586N6863530Novo SurgicalN6863-53N6863-532023-12-18
G586N6863540Novo SurgicalN6863-54N6863-542023-12-18
G586N6863550Novo SurgicalN6863-55N6863-552023-12-18
G586N6863580Novo SurgicalN6863-58N6863-582023-12-18
G586N6863590Novo SurgicalN6863-59N6863-592023-12-18
G586N98831250Novo SurgicalN98831-25N98831-252023-12-18
00842331174377Novo Surgical Inc. N3807-12N3807-122022-11-14
00842331153556Novo Surgical Inc. N6863-52N6863-522022-11-12
00842331165771Novo Surgical Inc. N6863-56N6863-562022-11-13
00842331169717Novo Surgical Inc. N6863-57N6863-572022-11-13
00842331170836Novo Surgical Inc. N3807-13N3807-132022-11-13
00842331194023Novo Surgical Inc. OP7195-242023-12-07
G586NS41500200Novo SurgicalNS4150020NS41500202025-09-15
G586NS41500250NovosurgicalNS4150025NS41500252025-09-15
G586NS720151200Novo SurgicalNS720-1512-02025-09-15
G586NS720155800Novo Surgical IncNS720-1558-0NS720-1558-02025-09-15
00842331192968Novo Surgical IncG1911-38IG-NS2023-08-21
G586NS80292210Novo SurgicalNS80-2922-1NS80-2922-12025-05-19
G586N8810500Novo SurgicalN8810-502025-05-19

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