FDA.reportPublic FDA data

Proficient® Posterior Cervical Spine System

Primary DI
10840642180299
Brand
Proficient® Posterior Cervical Spine System
Company
Spine Wave, Inc.
Model
10-8131
Catalog number
10-8131
Device description
Tap, 3.3 mm, NAV-M
Published
2026-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181596000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181596000Spine Wave Navigated InstrumentsSpine Wave, Inc.2018-10-24OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840642180299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084064218029910840642180299

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
203-944-9494info@spinewave.com

Regulatory Flags#

DUNS number
067789763
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840642132786Proficient® Posterior Cervical Spine System10-854610-85462026-10-21
10840642132793Proficient® Posterior Cervical Spine System10-854710-85472026-10-21
10840642149890Proficient® Posterior Cervical Spine System10-852910-85292026-10-21
10840642149906Proficient® Posterior Cervical Spine System10-853010-85302026-10-21
10840642151282Proficient® Posterior Cervical Spine System10-860910-86092026-10-21
10840642151305Proficient® Posterior Cervical Spine System10-861010-86102026-10-21
10840642151312Proficient® Posterior Cervical Spine System10-859610-85962026-10-21
10840642182149Spine Wave Instruments10-020510-02052026-10-21
10840642182156Spine Wave Instruments10-020610-02062026-10-21
10840642182163Spine Wave Instruments10-020710-02072026-10-21
10840642149838Proficient® Posterior Cervical Spine System10-8524.110-8524.12026-10-20
10840642149845Proficient® Posterior Cervical Spine System10-8524.210-8524.22026-10-20
10840642168709Tornado™11-58052021-10-11
10840642159615Tornado™11-58002020-04-15
10840642159622Tornado™11-58012020-04-15
10840642159639Tornado™11-58022020-04-15
10840642159646Tornado™11-58032020-04-15
10840642159653Tornado™11-58042020-04-15
10840642134797Salvo® Spine System11-671111-67112026-07-16
10840642180305Proficient® Posterior Cervical Spine System10-813210-81322026-07-13

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00889024705999NavitrackerOrthosoft IncOLO2026-10-26
00763000777500MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-25
00763000777623MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-25
00763000786434MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-25
00763000777616CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-23
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00840606184656OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187503OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187527OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187541OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
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00190376632919InvictusALPHATEC SPINE, INC.OLO2026-10-20
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00889024699816ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699823ROSA® ShoulderOrthosoft IncOLO2026-06-26
00887868581083ROSA® RoboticsOrthosoft IncOLO2026-02-20
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