FDA.reportPublic FDA data

7D Surgical Universal Array (5)

Primary DI
00628341521383
Brand
7D Surgical Universal Array (5)
Company
7D Surgical ULC
Model
11-0141
Published
2025-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K192140000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1921400007D Surgical System7D Surgical, Inc.2019-11-05OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628341521383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628341521383006283415213836283415213830628341521383

GMDN Terms#

Term, Definition table
TermDefinition
Surgical optical-tracking spatial marker connectorA component of a surgical navigation and/or device tracking system (e.g., optical/electromagnetic device tracking system, computer-assisted neurosurgical ultrasound navigation system) intended to connect the system’s spatial marker [localizer/tracker/calibrator (e.g., infrared light reflector)] to a navigated surgical instrument (e.g., a stereotactic surgery system probe, dental drill), and/or to another marker; it may be affixed via dedicated screws. It is typically made of metallic or polymer materials and may be in the shape of a handle to facilitate handling the instrument during a procedure. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
204326292
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628341520775Short Drill Guide Sterilization Tray11-00912022-04-07
006283415208297D Surgical FLASH EVD Procedural Kit11-00722026-04-08
006283415208367D Surgical FLASH EVD Non-Sterile Kit11-00732026-04-08
006283415208437D Surgical FLASH EVD Sterile Kit11-00742026-04-08
00628341521352FLASH EVD System10-00022026-04-08
006283415214067D Surgical Universal Tracking Sterilization Tray11-01432025-09-17
006283415213907D Surgical Universal Array (6)11-01422025-07-28
006283415209047D Surgical Iliac Cross Pin, 100 mm11-01012023-02-21
006283415209357D Surgical Iliac Cross Pin, 150 mm11-01042023-02-21
006283415201887D Surgical Steinmann Pin (ø3.2mm x 150mm) 11-00312021-07-27
006283415201957D Surgical Steinmann Pin (ø4.0mm x 150mm)11-00322021-07-27
006283415210557D Surgical Iliac Dual Pin Sterilization Tray11-01252024-07-19
006283415208507D Surgical Reference Clamp (Gator)11-00962023-01-12
006283415210247D Surgical Flex Rod Connector (4.5 mm - 100 mm)11-01132023-08-18
006283415208747D Surgical Spine Reference Clamp (Multi-Level)11-00982023-07-31
006283415207997D Surgical Pedicle Probe (Slim)11-00922022-09-21
006283415208057D Surgical Universal Array 311-00932022-09-21
006283415208127D Surgical Universal Array 411-00942022-09-21
006283415205777D Surgical Universal Clamp (Stryker Adapter)11-006711-00672020-11-18
006283415206907D Surgical Universal Clamp (SeaSpine Adapter)11-00792022-01-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840466901622PrimusSPINAL ELEMENTS, INC.OLO2026-07-21