FDA.reportPublic FDA data

STRAIGHT ENTRY AWL

Primary DI
M209216650
Brand
STRAIGHT ENTRY AWL
Company
BIOPRO, INC.
Model
21665
Published
2019-06-12
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163627000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163627000Shotel Ankle Arthrodesis Nail SystemBiopro, Inc.2017-09-14HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M209216650PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone awlA spike-like, orthopaedic, surgical instrument that is used to bore holes in bone. It is typically designed as 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. It is manually-operated by the surgeon who rotates the point back and forth on the bone whilst exerting pressure onto the handle. This operation will penetrate the hard outer bone and create a passage into, e.g., a medullary canal. It is typically made of high-grade stainless steel, titanium (Ti) and a synthetic material for the handle (e.g., Tufnol). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
618749857
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M209169570ACCU-CUT™ TWO STAGE169572015-09-16
M209169580ACCU-CUT™ TWO STAGE S169582015-09-16
M209173000ACCU-CUT™ 3mm OFFSET173002015-09-16
M209173060ACCU-CUT™ 3mm OFFSET S173062015-09-16
M209175020ACCU-CUT™ STANDARD W/2 BLADES175022015-09-16
M209175030ACCU-CUT™ 1mm OFFSET W/2 BLADES175032015-09-16
M209175040ACCU-CUT™ 2mm OFFSET W/2 BLADES175042015-09-16
M209175050ACCU-CUT™ 3mm OFFSET W/2 BLADES175052015-09-16
M209175060ACCU-CUT™ TWO STAGE W/2 BLADES175062015-09-16
M209177210ACCU-CUT™ STD MICRO CHOICE177212015-09-16
M209177330ACCU-CUT™ 1 mm MICRO CHOICE177332015-09-16
M209177340ACCU-CUT™ 2 mm MICRO CHOICE177342015-09-16
M209177350ACCU-CUT™ TWO STAGE MICRO177352015-09-16
M209185780ACCU-CUT™ 2mm W/THREADED K-WIRES185782015-09-16
M209195050ACCU-CUT™ STANDARD195052015-09-16
M209195060ACCU-CUT™ 1MM195062015-09-16
M209195070ACCU-CUT™ 2MM195072015-09-16
M209195080ACCU-CUT™ 3MM195082015-09-16
M209195090ACCU-CUT™ TWO STAGE195092015-09-16
M209195100ACCU-CUT™ LONG ARM195102015-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150076482Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-08-03
00199150076499Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-08-03
00840606191586Overwatch PCFSPINAL ELEMENTS, INC.HWJ2026-07-31
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