FDA.reportPublic FDA data

Kestrel®

Primary DI
M711LS4340
Brand
Kestrel®
Company
INNO Holdings, Inc.
Model
LS-434
Catalog number
LS-434
Device description
SST, Al, Silicone
Published
2018-09-30
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
K181063000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181063000Kestrel™ Buttress Plate SystemInnovasis, Inc.2018-07-13KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711LS4340PrimaryHIBCC0

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
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
M711511612120Endeavor™ Stand-Alone Cervical51-1612122026-05-31
M711511806070Endeavor™ Stand-Alone Cervical51-1806072026-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311248360Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248421Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248438Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248445Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248452Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248513Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840493422398RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422404RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422411RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422428RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422435RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422442RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422459RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422466RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422473RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422480RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422497RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422503RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422510RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422527RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422534RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422541RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422558RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422565RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422572RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422589RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840311263042Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263059Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263066Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263073Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02