FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9142211000
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD914221100
Catalog number
SD914221100
Device description
5 3/4" Kirschner Bow, Small
Published
2026-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD9142211000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 519-3293info@surgicaldirect.com

Regulatory Flags#

DUNS number
124367223
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
B382SD9141791400Surgical DirectSD914179140SD9141791402026-07-13
B382SD914264010Surgical DirectSD91426401SD914264012026-07-13
B382SD914341100Surgical DirectSD91434110SD914341102026-07-13
B382SD9143681000Surgical DirectSD914368100SD9143681002026-07-13
B382SD91705515T0Surgical DirectSD91705515TSD91705515T2026-07-13
B382SD91705525T0Surgical DirectSD91705525TSD91705525T2026-07-13
B382SD9176201020Surgical DirectSD917620102SD9176201022026-07-13
B382SD918006150Surgical DirectSD91800615SD918006152026-07-13
B382SD918006200Surgical DirectSD91800620SD918006202026-07-13
B382SD918174150Surgical DirectSD91817415SD918174152026-07-13
B382SD9183701030Surgical DirectSD918370103SD9183701032026-07-13
B382SD9183761030Surgical DirectSD918376103SD9183761032026-07-13
B382SD9184571000Surgical DirectSD918457100SD9184571002026-07-13
B382SD9184932000Surgical DirectSD918493200SD9184932002026-07-13
B382SD9153301000Surgical DirectSD915330100SD9153301002022-12-05
B382SD883110450Surgical DirectSD88311045SD883110452026-07-10
B382SD88324450Surgical DirectSD8832445SD88324452026-07-10
B382SD9032161000Surgical DirectSD903216100SD9032161002026-07-10
B382SD90390213SC0Surgical DirectSD90390213SCSD90390213SC2026-07-10
B382SD9044561000Surgical DirectSD904456100SD9044561002026-07-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606188128Ventana ASPINAL ELEMENTS, INC.LXH2026-07-13
B382SD9141791400Surgical DirectSurgical Direct, Inc.LXH2026-07-13
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00840286860093Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00190446924838Arsenal FootTrilliant Surgical, LLCLXH2026-06-24
00190446948469Arsenal FootTrilliant Surgical, LLCLXH2026-06-24
00190446948476Arsenal FootTrilliant Surgical, LLCLXH2026-06-24
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00840067212264TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212271TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212288TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212295TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
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00889929072776NEXXT MATRIXX® Stand Alone ALIF SystemNEXXT SPINE, LLCLXH2026-06-24
00889929072783NEXXT MATRIXX® Stand Alone ALIF SystemNEXXT SPINE, LLCLXH2026-06-24
04046826486631Stern-a-Fix Sternal Closure SystemMedicon eG. Chirurgiemechaniker-GenossenschaftLXH2026-06-24
07899258602042Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-06-24