FDA.reportPublic FDA data

Proficient® Posterior Cervical Spine System

Primary DI
10840642180312
Brand
Proficient® Posterior Cervical Spine System
Company
Spine Wave, Inc.
Model
10-8133
Catalog number
10-8133
Device description
Tap, 4.1 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
10840642180312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084064218031210840642180312

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
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
10840642180299Proficient® Posterior Cervical Spine System10-813110-81312026-07-13
10840642180305Proficient® Posterior Cervical Spine System10-813210-81322026-07-13
10840642180329Proficient® Posterior Cervical Spine System10-813410-81342026-07-13
10840642180336Proficient® Posterior Cervical Spine System10-813510-81352026-07-13
10840642180343Proficient® Posterior Cervical Spine System10-813610-81362026-07-13
10840642180350Proficient® Posterior Cervical Spine System10-813710-81372026-07-13
10840642107739Bifurcated Retractor Illuminator SWC-04SWC-042016-09-25
10840642174410Salvo® Spine System21-003921-00392026-04-13
10840642174434Salvo® Spine System21-004121-00412026-04-13
10840642174632Salvo® Spine System21-006121-00612026-04-13
10840642174649Salvo® Spine System21-006221-00622026-04-13
10840642174694Salvo® Spine System21-006721-00672026-04-13
10840642174878Salvo® Spine System21-008521-00852026-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04056481147969Spine and Trauma NavigationBrainlab SEOLO2026-10-19
00889024713390ROSA® ShoulderOrthosoft IncOLO2026-10-15
00885556919781Real IntelligenceSmith & Nephew, Inc.OLO2026-10-13
10705034648194VELYSMedos International SàrlOLO2026-10-09
10705034648200VELYSMedos International SàrlOLO2026-10-09
00885556924327Real IntelligenceSmith & Nephew, Inc.OLO2026-10-08
00889024673403NavitrackER®Orthosoft IncOLO2026-06-26
04056481146702Curve NavigationBrainlab SEOLO2025-10-13
07613327631814RPSStryker Leibinger GmbH & Co. KGOLO2025-10-03
04056481146054Patient Reference Rod-Clamp Spine & TraumaBrainlab SEOLO2025-09-19
04056481145439PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE SBrainlab SEOLO2025-06-17
04056481145446PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE LBrainlab SEOLO2025-06-17
07613252196259FLUOROMAPStryker Leibinger GmbH & Co. KGOLO2025-01-28
07613252286622FLUOROMAPStryker Leibinger GmbH & Co. KGOLO2025-01-28
04056481144906Spine &Trauma NavigationBrainlab SEOLO2024-11-14
04056481146238PATIENT REFERENCE ARRAY SPINE & TRAUMABrainlab SEOLO2024-11-14
04056481146603ADAPTER SHORT FOR PATIENT REFERENCE CLAMPBrainlab SEOLO2024-11-14
04056481146610ADAPTER X-PRESS FOR PATIENT REFERENCE ARRAYBrainlab SEOLO2024-11-14
04056481144753Drill Guide ArrayBrainlab SEOLO2024-06-04
04056481144760Drill Guide Depth Control (60 - 100 mm)Brainlab SEOLO2024-06-04
04056481144777Drill Guide Depth Control (0 - 60 mm)Brainlab SEOLO2024-06-04
04056481144784Drill Guide Tube (4.5 mm)Brainlab SEOLO2024-06-04
04056481144791Drill Guide Tube (3.2 mm)Brainlab SEOLO2024-06-04
04056481144807Drill Guide Tube (2.6 mm)Brainlab SEOLO2024-06-04
04056481144814Drill Guide Tube (2.4 mm)Brainlab SEOLO2024-06-04
04056481144821Drill Guide Tube (2.0 mm)Brainlab SEOLO2024-06-04
04056481144838Drill Guide HandleBrainlab SEOLO2024-06-04
04056481145057Drill Guide Trocar Insert (2.0 mm)Brainlab SEOLO2024-06-04
04056481145064Drill Guide Trocar Insert (2.4 mm)Brainlab SEOLO2024-06-04
04056481145071Drill Guide Trocar Insert (2.6 mm)Brainlab SEOLO2024-06-04