FDA.reportPublic FDA data

HBS DRILL COLLET ASSEMBLY STERILE

Primary DI
00810012484244
Brand
HBS DRILL COLLET ASSEMBLY STERILE
Company
BIOPRO, INC.
Model
19683
Published
2019-06-06
Public version status
Update
Distribution status
Not 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
LXIGuide, Drill, Ligament

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXIGuide, Drill, LigamentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101030000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101030000MODIFICATION TO HBS HEADLESS BONE SCREWBiopro, Inc.2010-06-03HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810012484244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810012484244008100124842448100124842440810012484244

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, single-useA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use device.

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
M209232580Hintermann Compressor232582026-05-22
M209232590Hintermann Distractor232592026-05-22
M20918608010mm HBS® Standard Compression186082015-09-16
M20918609011mm HBS® Standard Compression186092015-09-16
M20918610012mm HBS® Standard Compression186102015-09-16
M20918611013mm HBS® Standard Compression186112015-09-16
M20918612014mm HBS® Standard Compression186122015-09-16
M20918613015mm HBS® Standard Compression186132015-09-16
M20918614016mm HBS® Standard Compression186142015-09-16
M20918615017mm HBS® Standard Compression186152015-09-16
M20918616018mm HBS® Standard Compression186162015-09-16
M20918617019mm HBS® Standard Compression186172015-09-16
M20918618020mm HBS® Standard Compression186182015-09-16
M20918619021mm HBS® Standard Compression186192015-09-16
M20918620022mm HBS® Standard Compression186202015-09-16
M20918621023mm HBS® Standard Compression186212015-09-16
M20918622024mm HBS® Standard Compression186222015-09-16
M20918623025mm HBS® Standard Compression186232015-09-16
M20918624026mm HBS® Standard Compression186242015-09-16
M20918625027mm HBS® Standard Compression186252015-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G453332321055BC010PEAK MEDICALPeak Medical Distribution Inc.LXI2026-05-06
00888867500884Arthrex®ARTHREX, INC.LXI2026-03-13
00888867500907Arthrex®ARTHREX, INC.LXI2026-03-13
00888867500938Arthrex®ARTHREX, INC.LXI2026-03-13
00888867500976Arthrex®ARTHREX, INC.LXI2026-03-13
00888867500990Arthrex®ARTHREX, INC.LXI2026-03-13
00840124521018PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-06-24
00840124519978PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124519985PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520189PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520226PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520233PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520257PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520264PolyLock AnkleFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520325PolyLock AnkleFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520332PolyLock AnkleFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124519572PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519589PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519602PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519619PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519664PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519671PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519688PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519695PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519701PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519732PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519787PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519794PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519800PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519831PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15