FDA.reportPublic FDA data

Innovasis® Cranial System

Primary DI
M711BTA990
Brand
Innovasis® Cranial System
Company
INNO Holdings, Inc.
Model
BTA-99
Catalog number
BTA-99
Published
2014-12-29
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
GWOPlate, Cranioplasty, Preformed, Alterable
GXRCover, Burr Hole
HBWFastener, Plate, Cranioplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWOPlate, Cranioplasty, Preformed, AlterableNeurology2
GXRCover, Burr HoleNeurology2
HBWFastener, Plate, CranioplastyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141644000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141644000INNOVASIS CRANIAL SYSTEMInnovasis, Inc.2014-11-07GWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711BTA990PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbableAn assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
801-261-2236info@innovasis.com

Regulatory Flags#

DUNS number
141620464
Device count
1
DM exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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M711620155600Vector™ Pedicle Screw System62-0155602026-09-30
M711620155650Vector™ Pedicle Screw System62-0155652026-09-30
M711620155700Vector™ Pedicle Screw System62-0155702026-09-30
M711620155750Vector™ Pedicle Screw System62-0155752026-09-30
M711620155800Vector™ Pedicle Screw System62-0155802026-09-30
M711620155850Vector™ Pedicle Screw System62-0155852026-09-30
M711620155900Vector™ Pedicle Screw System62-0155902026-09-30
M711620155950Vector™ Pedicle Screw System62-0155952026-09-30
M711BTA2020Vector™ Pedicle Screw SystemBTA-2022026-06-05
M711LS7490Vector™ Pedicle Screw SystemLS-7492026-06-05
M711511410070Endeavor™ Stand-Alone Cervical51-1410072026-05-31
M711511410120Endeavor™ Stand-Alone Cervical51-1410122026-05-31
M711511411070Endeavor™ Stand-Alone Cervical51-1411072026-05-31
M711511411120Endeavor™ Stand-Alone Cervical51-1411122026-05-31
M711511412070Endeavor™ Stand-Alone Cervical51-1412072026-05-31
M711511412120Endeavor™ Stand-Alone Cervical51-1412122026-05-31
M711511606070Endeavor™ Stand-Alone Cervical51-1606072026-05-31
M711511607070Endeavor™ Stand-Alone Cervical51-1607072026-05-31
M711511607120Endeavor™ Stand-Alone Cervical51-1607122026-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00810228570595CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570601FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570540CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-07
00810228570557CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-07
00810228570564CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-07
00810228570519CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-01
00810228570526FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-01
00810228570533CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-01
00810228570465FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570472CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570489CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570496FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570502FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570458CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-21
00810228570373CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570380CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570397FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570403CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570410FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570427FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570434FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570441FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570137CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-08-17
00810228570144FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-08-17
00810228570151CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-08-17
00810228570168CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-08-17
00810228570175FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-08-17
00810228570182FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-08-17