FDA.reportPublic FDA data

Deluxe Bone Reduction Clamp

Primary DI
00192896122208
Brand
Deluxe Bone Reduction Clamp
Company
SONTEC INSTRUMENTS, INC.
Model
1103-046NL
Catalog number
1103-046NL
Device description
Deluxe Bone Reduction Clamp Narrow Serrated Pointed Jaws With Extra Long Ratchet
Published
2025-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXDCLAMP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXDClampGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896122208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896122208001928961222081928961222080192896122208

GMDN Terms#

Term, Definition table
TermDefinition
Bone approximation clampA hand-held manual surgical instrument designed to grip and hold a bone or, being used in pairs one on either side of the fracture, to approximate the proximal and distal segment of a fractured bone during orthopaedic surgery. It is typically made of high-grade stainless steel and is designed with a double hooked, blade-like jaw at the distal end (this hooks over the upper edge of the bone) whilst an adjustable single hook is tightened against the lower edge of the bone through a screw mechanism. A traction bar may be employed to bridge the two bone clamps and using its screw mechanism, the fracture is drawn together. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5.25Inch

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896123861Sheen Mini Cartilage Cutting Block350-845M350-845M2026-10-14
00192896123878Allis Tissue Forceps140-331Q140-331Q2026-10-14
00192896123885Allis Tissue Forceps140-330AQ140-330AQ2026-10-14
00192896123892Ceramitec Debakey Forceps2200-168CL2200-168CL2026-10-14
00192896123908Debakey Forceps2200-168L2200-168L2026-10-14
00192896123915Ceramitec Debakey Forceps2200-172CL2200-172CL2026-10-14
00192896123922Knurled Nut2500-200-1B2500-200-1B2026-10-14
00192896123939Bishop Harmon Tissue Forceps14-380114-38012026-10-14
00192896097049Laparoscopic Bulldog Clamp Forceps2901-2812901-2812019-05-09
00192896097056Laparoscopic Bulldog Clamp2901-281-252901-281-252019-05-09
00192896097063Laparoscopic Bulldog Clamp2901-281-402901-281-402019-05-09
00192896123793Adson Tissue Forceps140-302DLQ140-302DLQ2026-10-06
00192896123809Micro Skinner Forceps140-519M140-519M2026-10-06
00192896123816Jacobson Needle Holder2300-142D2300-142D2026-10-06
00192896123823Thumb Dressing Forceps136-610Q136-610Q2026-10-06
00192896123830Thumb Dressing Forceps136-615Q136-615Q2026-10-06
00192896123847Thumb Dressing Forceps136-619Q136-619Q2026-10-06
00192896123854Gum Scissors475-153Q475-153Q2026-10-06
00192896111394Laparoscopic Bulldog Clamp2901-281-60T2901-281-60T2021-10-22
00192896056282ALLIGATOR FORCEPS1271-0101271-0102018-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435349MillenniumAvalign Technologies, Inc.HXD2026-10-19
00190776433055MillenniumAvalign Technologies, Inc.HXD2026-10-01
B382SD9017971000Surgical DirectSurgical Direct, Inc.HXD2026-08-21
00190776426606MillenniumAvalign Technologies, Inc.HXD2026-08-19
00840277133779Innomed, Inc.INNOMED, INC.HXD2026-08-18
00840277133786Innomed, Inc.INNOMED, INC.HXD2026-08-18
05060624127007CS Mayfield / Doro AdaptorsCARE SURGICAL LIMITEDHXD2026-08-07
00190776405786MillenniumAvalign Technologies, Inc.HXD2026-07-24
04058749047981NAFehling Instruments GmbH & Co. KGHXD2026-07-17
B8034503260ORTHOMEDORTHO-MED, INC.HXD2026-07-14
B8034503660ORTHOMEDORTHO-MED, INC.HXD2026-07-14
B8034503700ORTHOMEDORTHO-MED, INC.HXD2026-07-14
00840277133656Innomed, Inc.INNOMED, INC.HXD2026-05-29
ESAM3840131STOMA®Storz am Mark GmbHHXD2025-04-30
ESAM3841131STOMA®Storz am Mark GmbHHXD2025-04-30
00840314269690gSourceGSOURCE LLCHXD2025-01-15
00840314269591gSourceGSOURCE LLCHXD2024-08-14
10840199539571Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539588Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539595Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539601Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539618Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539625Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539632Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539649Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199535894ClampKOROS U.S.A., INC.HXD2024-01-31
10840199535948Cardio ClampKOROS U.S.A., INC.HXD2024-01-31
10840199535955Cardio ClampKOROS U.S.A., INC.HXD2024-01-31
10840199535979Aortic ClampKOROS U.S.A., INC.HXD2024-01-31
10840199536013Aortic ClampKOROS U.S.A., INC.HXD2024-01-31