FDA.reportPublic FDA data

HBS2

Primary DI
00850005146780
Brand
HBS2
Company
HNM STUCKENBROCK, INC.
Model
HS-26-800-14-09
Catalog number
HS-26-800-14-09
Device description
HBS 2 MIDI SHORT THREAD, 14MM, CAN/SD/TI
Published
2020-12-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171628000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171628000HBS2 Headless Bone ScrewStuckenbrock Medizintechnik GmbH2018-01-12HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005146780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005146780008500051467808500051467800850005146780

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
117068079
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005146759HBS2HS-26-800-11-09HS-26-800-11-092020-12-25
00850005146766HBS2HS-26-800-12-09HS-26-800-12-092020-12-25
00850005146773HBS2HS-26-800-13-09HS-26-800-13-092020-12-25
00850005146797HBS2HS-26-800-15-09HS-26-800-15-092020-12-25
00850005146803HBS2HS-26-800-16-09HS-26-800-16-092020-12-25
00850005146810HBS2HS-26-800-17-09HS-26-800-17-092020-12-25
00850005146827HBS2HS-26-800-18-09HS-26-800-18-092020-12-25
00850005146834HBS2HS-26-800-19-09HS-26-800-19-092020-12-25
00850005146841HBS2HS-26-800-20-09HS-26-800-20-092020-12-25
00850005146858HBS2HS-26-800-21-09HS-26-800-21-092020-12-25
00850005146865HBS2HS-26-800-22-09HS-26-800-22-092020-12-25
00850005146872HBS2HS-26-800-23-09HS-26-800-23-092020-12-25
00850005146889HBS2HS-26-800-24-09HS-26-800-24-092020-12-25
00850005146896HBS2HS-26-800-25-09HS-26-800-25-092020-12-25
00850005146902HBS2HS-26-800-26-09HS-26-800-26-092020-12-25
00850005146919HBS2HS-26-800-27-09HS-26-800-27-092020-12-25
00850005146926HBS2HS-26-800-28-09HS-26-800-28-092020-12-25
00850005146933HBS2HS-26-800-29-09HS-26-800-29-092020-12-25
00850005146940HBS2HS-26-800-30-09HS-26-800-30-092020-12-25
00850005146957HBS2HS-26-820-10-09HS-26-820-10-092020-12-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842188131615CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131639CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131653CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131677CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131721CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00889095401820ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401844ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401868ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401882ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401905ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401929ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402285ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402438ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402483ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402537ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411263ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411287ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411300ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411324ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095611274ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
10886982342508VOLTSynthes GmbHHWC2026-09-25
10886982342515VOLTSynthes GmbHHWC2026-09-25
10886982342522VOLTSynthes GmbHHWC2026-09-25
10886982342539VOLTSynthes GmbHHWC2026-09-25
10886982342546VOLTSynthes GmbHHWC2026-09-25
10886982342553VOLTSynthes GmbHHWC2026-09-25
10886982342560VOLTSynthes GmbHHWC2026-09-25
10886982342577VOLTSynthes GmbHHWC2026-09-25
10886982342584VOLTSynthes GmbHHWC2026-09-25
10886982342591VOLTSynthes GmbHHWC2026-09-25