FDA.reportPublic FDA data

BRIDALVEIL

Primary DI
00841379164029
Brand
BRIDALVEIL
Company
Astura Medical
Model
FZ5100000
Catalog number
FZ5100000
Device description
STICK FIT SCREW HEIGHT ADJUSTER
Published
2021-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
NKGPosterior Cervical Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171250000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171250000BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical2017-10-02NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841379164029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841379164029008413791640298413791640290841379164029

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a stabilization device (e.g., rod, plate) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7608148047PARKER@ASTURAMEDICAL.COM

Regulatory Flags#

DUNS number
073029645
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840085244919OLYMPICAZC010030AZC0100302026-04-15
00840085252761OLYMPICAZC170000AZC1700002026-04-15
00840085213120SIRIONGZC11D10AGZC11D10A2021-07-15
00841379186588SIRIONGZB13AE02GZB13AE022021-07-13
00840085201585SIRIONGZA150000GZA1500002021-07-12
00840085278518ALTANBT095060NBT0950602026-02-03
00840085277603ALTANBF045025NBF0450252026-02-02
00840085278051ALTANBF095060NBF0950602026-02-02
00840085278068ALTANBT045025NBT0450252026-02-02
00840085219641EL CAPITANKZB100000KZB1000002021-07-30
00840085233500DOLOMITELZA040000LZA0400002021-07-27
00840085233517DOLOMITELZA050000LZA0500002021-07-27
00840085233524DOLOMITELZA060000LZA0600002021-07-27
00840085235078DOLOMITELZB040000LZB0400002021-07-27
00840085235085DOLOMITELZB050000LZB0500002021-07-27
00840085236938DOLOMITELZD020000LZD0200002021-07-27
00840085236990DOLOMITELZD060000LZD0600002021-07-27
00840085242274DOLOMITELZD070000LZD0700002021-07-27
00840085272271ASYNJABB00025JABB000252024-01-09
00840085272288ASYNJABB00050JABB000502024-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840466901011PrimusSPINAL ELEMENTS, INC.KWP2026-10-22
00840019978156Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978163Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978170Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978187Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978194Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978200Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978217Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978224Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978231Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978248Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978255Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978262Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978279Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978286Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978293Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978309Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978316Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978323Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978330Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978347Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978354Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978361Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978378Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978385Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978392Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978408Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978415Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978422Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978439Reform TiPRECISION SPINE, INC.KWP2026-10-19