FDA.reportPublic FDA data

Decima Spine Instrument Kit

Primary DI
00857360007091
Brand
Decima Spine Instrument Kit
Company
DECIMA SPINE, INC.
Model
6119
Catalog number
6119
Device description
Tap
Published
2018-04-08
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
HWXTap, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857360007091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857360007091008573600070918573600070910857360007091

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw starter/notcherA hand-held surgical instrument used to create an indentation or enlarge a pre-drilled pilot hole in a bone that will enable the surgeon to begin threading a bone screw or place another form of anchoring device. This device, commonly known as a bone notcher, may function and be used in a variety of ways: 1) notch the bone such that the threads on a bone screw will bite into the bone; 2) simply hold the screw at the desired angle to the bone while the screw is driven into position; or 3) in the case of hard bone (e.g., on the glenoid) be inserted into a pilot hole where it is rotated to create a cavity within the soft bone for placement of, e.g., a suture anchor. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (954) 243-6103carlos@decimaspine.com

Regulatory Flags#

DUNS number
080963983
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857360007176FCD-2 IMPLANT SYSTEM90629062-002018-04-08
00857360007190FCD-2 IMPLANT SYSTEM90639063-002018-04-08
00857360007060Decima Spine Instrument Kit609560952018-04-04
00857360007213Decima Spine Instrument Kit613461342018-04-08
00857360007114Decima Spine Instrument Kit612861282018-04-08
00857360007138Decima Spine Instrument Kit613961392018-04-08
00857360007206Decima Spine Instrument Kit615861582018-04-08
00857360007053Decima Spine Instrument Kit609460942018-04-04
00857360007077Decima Spine Instrument Kit609660962018-04-04
00857360007015Decima Spine Instrument Kit607960792018-04-04
00857360007008Decima Spine Instrument Kit6072-006072-002018-04-08
00857360007084Decima Spine Instrument Kit611861182018-04-08
00857360007107Decima Spine Instrument Kit612061202018-04-08
00857360007145Decima Spine Instrument Kit9061-009061-002018-04-08
00857360007220Decima Spine Instrument Kit9067-009067-002018-04-08
00857360007039Decima Spine Instrument Kit6086-016086-012018-04-04
00857360007046Decima Spine Instrument Kit609360932018-04-04

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