FDA.reportPublic FDA data

Saw Blade

Primary DI
00810111225359
Brand
Saw Blade
Company
Treace Medical Concepts, Inc.
Model
SN43
Device description
Akin Saw Blade - SM
Published
2026-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GFABlade, Saw, General & Plastic Surgery, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810111225359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810111225359008101112253598101112253590810111225359

GMDN Terms#

Term, Definition table
TermDefinition
Surgical saw blade, sagittal, single-useA flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at the distal end to cut in a rapid sagittal (side to side) motion; it may in addition cut in an oscillating motion. This is a single-use device.

Regulatory Flags#

DUNS number
054808082
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810111227919BROACH02-005602026-09-30
00810111227926BROACH02-005592026-09-30
00810111227933BROACH02-005582026-09-30
00810111228527Drill Guide02-006302026-09-21
00810111224680TMC PSI Cut Guide SystemPSI-02-003862025-05-22
00810111224697TMC PSI Cut Guide SystemPSI-02-003852025-05-22
00810111223447TMC PSI Cut Guide SystemNK232024-11-14
00810111223454TMC PSI Cut Guide SystemNK242024-11-14
00810111223478TMC PSI Cut Guide SystemNK262024-11-14
00810111223553TMC PSI Cut Guide SystemPSI-02-002332024-11-15
00810111223560TMC PSI Cut Guide SystemPSI-02-002322024-11-15
00810111223577TMC PSI Cut Guide SystemPSI-02-002312024-11-15
00810111223584TMC PSI Cut Guide SystemPSI-02-002302024-11-15
00810111223621TMC PSI Cut Guide SystemNK272024-11-14
00810111222723TMC PSI Cut Guide SystemPSI-02-001632024-03-11
00810111222730TMC PSI Cut Guide SystemPSI-02-001622024-03-11
00810111222259TMC PSI Cut Guide SystemNK152023-11-17
00810111222266TMC PSI Cut Guide SystemPSI-01-2029-0212023-11-17
00810111222273TMC PSI Cut Guide SystemPSI-01-2229-0212023-11-17
00810111222280TMC PSI Cut Guide SystemPSI-01-2129-0212023-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14053613286371Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613286586Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613286593Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613286616Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613286647Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613286678Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613286746Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613286760Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613286951Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613286968Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613295663Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUMGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613295670Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUMGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613295687Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUMGebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613298145Oscillating Saw Blade for Arthrex 300Gebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613298152Oscillating Saw Blade for Arthrex 300Gebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613298169Oscillating Saw Blade for Arthrex 300Gebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613298176Oscillating Saw Blade for Arthrex 300Gebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613298183Oscillating Saw Blade for Arthrex 300Gebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613298190Oscillating Saw Blade for Arthrex 300Gebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613298206Reciprocating Saw Blade for ConMed®/Linvatec® Hall®Gebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613298213Reciprocating Saw Blade for Arthrex 300Gebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613298220Reciprocating Saw Blade for Arthrex 300Gebr. Brasseler GmbH & Co. KGGFA2026-10-07
14053613286302Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-05
14053613286326Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-05
14053613286418Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-05
14053613286432Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-05
14053613286661Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-05
14053613286708Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-05
14053613286814Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-05
14053613287026Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-10-05