FDA.reportPublic FDA data

Opteryx®

Primary DI
M711CI0600
Brand
Opteryx®
Company
INNO Holdings, Inc.
Model
CI-060
Catalog number
CI-060
Device description
Radel, SST
Published
2018-01-31
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
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061147000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061147000OPTERYX ANTERIOR CERVICAL PLATE SYSTEMInnovasis, Inc.2006-06-30KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711CI0600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

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
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
M711511608070Endeavor™ Stand-Alone Cervical51-1608072026-05-31
M711511608120Endeavor™ Stand-Alone Cervical51-1608122026-05-31
M711511609070Endeavor™ Stand-Alone Cervical51-1609072026-05-31
M711511609120Endeavor™ Stand-Alone Cervical51-1609122026-05-31
M711511610070Endeavor™ Stand-Alone Cervical51-1610072026-05-31
M711511610120Endeavor™ Stand-Alone Cervical51-1610122026-05-31
M711511611070Endeavor™ Stand-Alone Cervical51-1611072026-05-31
M711511611120Endeavor™ Stand-Alone Cervical51-1611122026-05-31
M711511612070Endeavor™ Stand-Alone Cervical51-1612072026-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986492791CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-09
08809986492807CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-09
08809986492814CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-09
00840493423166RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423173RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423197RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423234RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423241RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423258RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423265RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423272RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423289RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423296RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423302RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423319RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423326RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423333RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423340RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423357RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423364RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423371RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423388RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423395RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423401RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423418RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
00840493423425RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08