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
00810055251339Surgical DesignCLH-LG2026-06-09
00810055251346Surgical DesignCLH-MD2026-06-09
00810055251353Surgical DesignCLH-SM2026-06-09
00810055251360Surgical DesignCMC-02026-06-09
00810055251377Surgical DesignCMC-002026-06-09
00810055251384Surgical DesignCMC-12026-06-09
00810055251391Surgical DesignCMC-22026-06-09
00810055251414Surgical DesignCMC-42026-06-09
00810055251421Surgical DesignCMC-52026-06-09
00810055251445Surgical DesignCML-02026-06-09
00810055251452Surgical DesignCML-002026-06-09
00810055251469Surgical DesignCML-12026-06-09
00810055251476Surgical DesignCML-22026-06-09
00810055251483Surgical DesignCML-32026-06-09
00810055251490Surgical DesignCML-42026-06-09
00810055251506Surgical DesignCML-52026-06-09
00810055257744Surgical DesignDFLS-05MC2026-06-09
00810055257768Surgical DesignDFLS-05ML2026-06-09
00810055257782Surgical DesignDFLS-122026-06-09
00810055251520Surgical DesignCSS-55-01TC2026-06-06

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
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