FDA.reportPublic FDA data

Surgical Design

Primary DI
00810189451483
Brand
Surgical Design
Company
Surgical Design, Inc.
Model
11-211-01
Device description
Skull Crusher Hammer
Published
2026-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZYHammer, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZYHammer, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810189451483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810189451483008101894514838101894514830810189451483

GMDN Terms#

Term, Definition table
TermDefinition
Surgical malletA hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.

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
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
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
00810189451162Surgical DesignSurgical Design, Inc.FZY2026-05-23
10705034579023N/AMedos International SàrlFZY2026-03-05
03662663083638ActivLHighridge Medical, LLCFZY2026-02-03
03662663083645ActivLHighridge Medical, LLCFZY2026-02-03
03662663083652ActivLHighridge Medical, LLCFZY2026-02-03
03662663083669ActivLHighridge Medical, LLCFZY2026-02-03
03662663083676ActivLHighridge Medical, LLCFZY2026-02-03
03662663083690ActivLHighridge Medical, LLCFZY2026-02-03
03662663155618Zyston Interbody Spacer SystemHighridge Medical, LLCFZY2025-12-29
03662663155762Zyston Interbody Spacer SystemHighridge Medical, LLCFZY2025-12-29
03662663155779Zyston Interbody Spacer SystemHighridge Medical, LLCFZY2025-12-29
03662663244695Vital MIS Spinal Fixation SystemHighridge Medical, LLCFZY2025-12-18
04262494463150N/ADoppkon GmbH & Co. KGFZY2025-12-04
04262494463174N/ADoppkon GmbH & Co. KGFZY2025-12-04
04262494463167N/ADoppkon GmbH & Co. KGFZY2025-11-28
03662663216951Telluride MIS Spinal Fixation SystemHighridge Medical, LLCFZY2025-11-17
03662663267205Timberline Lateral Fusion SystemHighridge Medical, LLCFZY2025-11-16
03662663267601Timberline Lateral Fusion SystemHighridge Medical, LLCFZY2025-11-16
03662663279123Timberline Lateral Fusion SystemHighridge Medical, LLCFZY2025-11-16
04059453096517Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFZY2025-08-25
04262494460562N/ADoppkon GmbH & Co. KGFZY2025-08-05
10889981322144REEF LSeaspine Orthopedics CorporationFZY2025-07-15
00199150021550Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.FZY2025-07-13
00840019959766ShurFit Lumbar InterbodyPRECISION SPINE, INC.FZY2025-05-29
00840194472371PNP FemurORTHOPEDIATRICS CORP.FZY2025-05-28
00840194472388PNP FemurORTHOPEDIATRICS CORP.FZY2025-05-28
00840194472395PNP FemurORTHOPEDIATRICS CORP.FZY2025-05-28
00840286841597Consensus Hip System/UniSyn Hip SystemShalby Advanced Technologies, Inc.FZY2025-05-22
00840286845588Consensus Knee SystemShalby Advanced Technologies, Inc.FZY2025-05-21
00840277132178Innomed, Inc.INNOMED, INC.FZY2025-05-06