FDA.reportPublic FDA data

Isto Disposable Awl 8.5/9.0 Anchor

Primary DI
B90839940859310
Brand
Isto Disposable Awl 8.5/9.0 Anchor
Company
Mainstream Medical Devices, LLC
Model
399-40-859-310
Catalog number
IFLX-DA-8590
Device description
Disposable Awl 8.5/9.0 Anchor
Published
2023-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWJAwl

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B90839940859310PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone awl, single-useA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071513432
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B90829211908Main-AXS Needle-Retropsoas292-11-908292-11-9082025-04-30
B90830825080Main-Mallet308-25-080308-25-0802025-04-04
B90831225080Main-Mallet312-25-080312-25-0802025-04-04
B90831625080Main-Mallet316-25-080316-25-0802025-04-04
B90831635080Main-Mallet316-35-080316-35-0802025-04-04
B908350011000Main-Mallet-Spinal Simplicity316-35-91135-0011-0002025-04-04
B908350008000Main-AXS Needle-Spinal Simplicity292-11-92035-0008-0002024-12-03
B908350009000Main-AXS Needle-Spinal Simplicity299-08-90035-0009-0002024-12-03
B90831020150Sterile Drill Bit310-20-150310-20-1502024-08-09
B90831020150907Sterile Drill Bit - RMR310-20-150-90707.20.QDS2024-08-09
B90831025150Sterile Drill Bit310-25-150310-25-1502024-08-09
B90831027150Sterile Drill Bit310-27-150310-27-1502024-08-09
B90831027150907Sterile Drill Bit - RMR310-27-150-90707.27.QDS2024-08-09
B90831032150Sterile Drill Bit310-32-150310-32-1502024-08-09
B90831032150907Sterile Drill Bit - RMR310-32-150-90707.32.QDS2024-08-09
B9081600051Main-Knife RIGID 21mm, Alphatec451-25-9011600-052024-03-02
B9081600060Main-Knife - Alphatec471-25-9011600-062024-03-02
B90847125901Main-Knife - Alphatec471-25-9011600-062024-02-21
B90845125901Main-Knife RIGID 21mm, Alphatec451-25-9011600-052023-07-12
B90847125193Main-Knife - Alphatec471-25-193471-25-1932024-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000879556MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-07-20
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-07-19
18257200051175PROVIEWOrthofix US LLCHWJ2026-07-17
18257200163571PILLAR SA TiOrthofix US LLCHWJ2026-07-17
18257200163588PILLAR SA TiOrthofix US LLCHWJ2026-07-17
18257200163595PILLAR SA TiOrthofix US LLCHWJ2026-07-17
B8034609130ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034609140ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034609150ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034609160ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803030ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803360ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803370ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803380ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803390ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803400ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803410ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
00857915007767IM Nail AwlA.M. SURGICAL, INC.HWJ2026-06-10
00840311245376Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HWJ2026-04-30
08800322758137Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWJ2026-04-21
00860015151308EnFix Instrument Kit - CompleteTETROUS, INC.HWJ2026-02-24
00887868287473Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCHWJ2025-11-12
07640375234773SCARLET AL-T INSTRUMENTATIONSpineArt SAHWJ2025-11-10
08059386744338Orthopaedic Surgical InstrumentsCITIEFFE SRLHWJ2025-11-06
00763000674410n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-26
09120129291507Awl, Curved, CannulatedI.T.S. GmbHHWJ2025-10-21
09120129291514Awl TrocarI.T.S. GmbHHWJ2025-10-21
00763000878245n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-20
00840180541050General InstrumentsALPHATEC SPINE, INC.HWJ2025-10-17
00763000885243n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-11