FDA.reportPublic FDA data

Decima Spine Instrument Kit

Primary DI
00857360007060
Brand
Decima Spine Instrument Kit
Company
DECIMA SPINE, INC.
Model
6095
Catalog number
6095
Device description
INSERTION TOOL
Published
2018-04-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857360007060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857360007060008573600070608573600070600857360007060

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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
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
00857360007091Decima Spine Instrument Kit611961192018-04-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982345462VOLTSynthes GmbHHXX2026-09-25
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00840606191616Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
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00840606191746Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
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00840606191784Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191944Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191951Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191982Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
03701089540643AMPLITUDEAMPLITUDE SASHXX2026-07-29
03701089541022AMPLITUDEAMPLITUDE SASHXX2026-07-29
03700569670269Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
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03700569680299Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
00824846003199Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-26
00824846003205Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-26
10887587078557NASynthes GmbHHXX2026-07-24
10887587078564NASynthes GmbHHXX2026-07-24
00888118154644LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21