FDA.reportPublic FDA data

Surgical Design

Primary DI
00810055254040
Brand
Surgical Design
Company
Surgical Design, Inc.
Model
ORG-151-01S
Published
2026-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00810055254040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055254040008100552540408100552540400810055254040

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature68 Degrees Fahrenheit72 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"

Contacts#

Phone, Email table
PhoneEmail
7035410196info@surgical-design.com

Regulatory Flags#

DUNS number
112617522
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
00810055250547Surgical Design141-07R-BL2026-05-26
00810055256211Surgical Design141-07-O2026-05-26
00810055256235Surgical Design141-07-PK2026-05-26
00810055256242Surgical Design141-07-RD2026-05-26
00810055256259Surgical Design141-07-YW2026-05-26
00810055258604Surgical Design141-07R2026-05-26
00810055258611Surgical Design141-07R-RD2026-05-26
00810055258628Surgical Design141-07R-GR2026-05-26
00810055258635Surgical Design141-07R-PK2026-05-26
00810055258642Surgical Design141-07R-PR2026-05-26
00810055258659Surgical Design141-07R-WH2026-05-26
00810055258666Surgical Design141-07R-TL2026-05-26
00810055258673Surgical Design141-07R-WY2026-05-26
00810055258680Surgical Design141-07F2026-05-26
00810055258697Surgical Design141-07-BL2026-05-26
00810055258703Surgical Design141-07-GR2026-05-26
00810055258710Surgical Design141-07-PR2026-05-26
00810055258727Surgical Design141-07-WH2026-05-26
00810055259663Surgical Design159R2026-05-26
00810055259670Surgical Design160R2026-05-26

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 SatterleeASPEN SURGICAL PRODUCTS, INC.HSO2024-08-12
G586N8813340Novo SurgicalNOVO SURGICAL, INC.HSO2023-12-18
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 SYSTEMOrthopediatrics Canada ULCHSO2023-11-16
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