FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331136627
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
N8755-13
Catalog number
N8755-13
Device description
boehler wire & pin extractor, 160.0 mm wide x 90.0 mm long
Published
2022-11-10
Public version status
Update
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
KQZComponent, Traction, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQZComponent, Traction, Non-InvasiveOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331136627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331136627008423311366278423311366270842331136627

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00848340016806ALLENHILL-ROM, INC.KQZ2026-04-24
00888867484986Arthrex®ARTHREX, INC.KQZ2025-12-10
00888867485099Arthrex®ARTHREX, INC.KQZ2025-12-10
00888867485105Arthrex®ARTHREX, INC.KQZ2025-12-10
00888867485112Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867484983Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485096Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485102Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485119Arthrex®ARTHREX, INC.KQZ2025-12-10
00810075281521BoneFoamBONE FOAM, INC.KQZ2025-08-15
00810075281491BoneFoamBONE FOAM, INC.KQZ2025-08-15
00810075281514BoneFoamBONE FOAM, INC.KQZ2025-08-15
00888867502710Arthrex®ARTHREX, INC.KQZ2025-08-14
10888867502717Arthrex®ARTHREX, INC.KQZ2025-08-14
20845854082925Paradigm RevolutionConmed CorporationKQZ2023-06-13
20845854082932Paradigm RevolutionConmed CorporationKQZ2023-06-13
0078755101165490403 Shoulder Arthroscopy KitXODUS MEDICAL, INC.KQZ2022-12-08
00787551011678NS90403 Shoulder Suspension KitXODUS MEDICAL, INC.KQZ2022-12-08
2078755101165890403 Shoulder Arthroscopy KitXODUS MEDICAL, INC.KQZ2022-12-08
20787551011672NS90403 Shoulder Suspension KitXODUS MEDICAL, INC.KQZ2022-12-08
00816342020718Accessories, arthroscopicPARCUS MEDICAL LLCKQZ2022-12-06
00842331141027Novo Surgical Inc. NOVO SURGICAL, INC.KQZ2022-11-11
00842331143373Novo Surgical Inc. NOVO SURGICAL, INC.KQZ2022-11-11
00610570001712"100 FT. 3/16"" TRACTION CORD"Bird & Cronin, LLCKQZ2022-08-20
00610570001750"1500 FT. 3/16"" TRACTION CORD"Bird & Cronin, LLCKQZ2022-08-20
00610570006588BUCKS BOOT XSBird & Cronin, LLCKQZ2022-08-20
00610570006595BUCKS BOOT SMBird & Cronin, LLCKQZ2022-08-20
00610570006601BUCKS BOOT MDBird & Cronin, LLCKQZ2022-08-20
00610570006618BUCKS BOOT LGBird & Cronin, LLCKQZ2022-08-20