FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586N8813340
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
N8813-34
Catalog number
N8813-34
Device description
langenbeck metacarpal saw, 11.4 cm wide, 9" (22.9 cm)
Published
2023-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
G586N8813340PrimaryHIBCC0

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
+1(877)860-6686info@novosurgical.com

Regulatory Flags#

DUNS number
033029433
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
G586N8810500Novo SurgicalN8810-502025-05-19
G586NS38796080NOVOSURGICALNS38-796-08NS38-796-082025-05-02
G586NS50468110Novo SurgicalNS50-4681-1NS50-4681-12025-05-02
G586G171631E0NovosurgicalG1716-31E2025-04-17
G586G311041NC0Novo SurgicalG3110-41NC2025-03-21
G586N697205A0NovosurgicalN6972-05AN6972-05A2025-02-06
G586N697206A0NovosurgicalN6972-06AN6972-05A2025-02-06
G586NS02533010Novo SurgicalNS02-5330-1NS02-5330-12025-02-06
G586NS5230002SPFB10Novo SurgicalNS52-300-02SPFB-1NS02-5330-12025-02-06
G5862562529S0Novosurgical25625-29S2025-01-02
G586N6969090NovosurgicalN6969-092025-01-02
G586N6971710NovosurgicalN6971-712025-01-02
G586N6971730NovosurgicalN6971-732025-01-02
G586N6972700NovosurgicalN6972-702025-01-02
G586NS47110610NovosurgicalNS47-1106-12025-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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 Surgical®SYMMETRY SURGICAL INC.HSO2024-08-12
G586N8815810Novo SurgicalNOVO SURGICAL, INC.HSO2023-12-18
G586N8816470Novo SurgicalNOVO SURGICAL, INC.HSO2023-12-18
G586N98813340Novo SurgicalNOVO SURGICAL, INC.HSO2023-12-18
G586N98814380Novo SurgicalNOVO SURGICAL, INC.HSO2023-12-18
G586N98814760Novo SurgicalNOVO SURGICAL, INC.HSO2023-12-18
G586N98815810Novo SurgicalNOVO SURGICAL, INC.HSO2023-12-18
G586N98816460Novo SurgicalNOVO SURGICAL, INC.HSO2023-12-18
G586N98816480Novo SurgicalNOVO SURGICAL, INC.HSO2023-12-18
07540194014245FASSIER-DUVAL TELESCOPIC IM SYSTEMPega Medical IncHSO2023-11-16
00819034027019DynaBridgeFUSION ORTHOPEDICS, LLCHSO2023-07-03
00819034029693DynaBridgeFUSION ORTHOPEDICS, LLCHSO2023-07-03
00840124507074LapiLockFUSION ORTHOPEDICS, LLCHSO2023-07-03
00840124507081LapiLockFUSION ORTHOPEDICS, LLCHSO2023-07-03
00840124507364LapiLockFUSION ORTHOPEDICS, LLCHSO2023-07-03
00840124507371LapiLockFUSION ORTHOPEDICS, LLCHSO2023-07-03
00819034027002DynaBridgeFUSION ORTHOPEDICS, LLCHSO2023-06-16
00840124507388DynaBridgeFUSION ORTHOPEDICS, LLCHSO2023-06-16
00889797075527INBONE™WRIGHT MEDICAL TECHNOLOGY, INC.HSO2022-11-16
00889797075534INBONE™WRIGHT MEDICAL TECHNOLOGY, INC.HSO2022-11-16
00889797075541INBONE™WRIGHT MEDICAL TECHNOLOGY, INC.HSO2022-11-16
00889797075558INBONE™WRIGHT MEDICAL TECHNOLOGY, INC.HSO2022-11-16
00889797075565INBONE™WRIGHT MEDICAL TECHNOLOGY, INC.HSO2022-11-16
00889797075572INBONE™WRIGHT MEDICAL TECHNOLOGY, INC.HSO2022-11-16
00842331188244Novo Surgical Inc. NOVO SURGICAL, INC.HSO2022-11-14