FDA.reportPublic FDA data

SABER-C RASP

Primary DI
00810017913411
Brand
SABER-C RASP
Company
ELEVATION SPINE, INC.
Model
CI-RASP2565
Catalog number
CI-RASP2565
Device description
Saber-C Rasp, 12x15x5, 6 deg.
Published
2024-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810017913411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017913411008100179134118100179134110810017913411

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
085718404
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
00810017913664Saber-C Body (PT), 12x15x7 6 deg.CBT-2567-PCBT-2567-P2026-06-05
00810017914609Saber-C Plate, 14x17x6 12 deg.CP-4726CP-47262026-06-05
00810017914616Saber-C Plate, 14x17x7 12 deg.CP-4727CP-47272026-06-05
00810017914623Saber-C Plate, 14x17x8 12 deg.CP-4728CP-47282026-06-05
00810017915354Saber-C, Spike Driver 5-7, MedialCI-DRIVER3M-5-7CI-DRIVER3M-5-72026-06-05
00810017915361Saber-C, Spike Driver 5-7, LateralCI-DRIVER3L-5-7CI-DRIVER3L-5-72026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialCI-DRIVER3M-8-9CI-DRIVER3M-8-92026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralCI-DRIVER3L-8-9CI-DRIVER3L-8-92026-06-05
00810017913657Saber-C Body (PT), 12x15x6 6 deg.CBT-2566-PCBT-2566-P2026-06-01
0081001791165312 (w) X 15 (d) Saber-C Cervical PlateCP-2568CP-25682019-12-20
0081001791166012 (w) X 15 (d) Saber-C Cervical PlateCP-2569CP-25692019-12-20
0081001791167712 (w) X 15 (d) Saber-C Cervical PlateCP-2561CP-25612019-12-20
0081001791168412 (w) X 15 (d) Saber-C Cervical PlateCP-2595CP-25952019-12-20
0081001791169112 (w) X 15 (d) Saber-C Cervical PlateCP-2596CP-25962019-12-20
0081001791170712 (w) X 15 (d) Saber-C Cervical PlateCP-2597CP-25972019-12-20
0081001791171412 (w) X 15 (d) Saber-C Cervical PlateCP-2598CP-25982019-12-20
0081001791172112 (w) X 15 (d) Saber-C Cervical PlateCP-2599CP-25992019-12-20
0081001791173812 (w) X 15 (d) Saber-C Cervical PlateCP-2591CP-25912019-12-20
0081001791174514 (w) X 15 (d) Saber-C Cervical PlateCP-4505CP-45052019-12-20
0081001791175214 (w) X 15 (d) Saber-C Cervical PlateCP-4506CP-45062019-12-20

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