VSP Orthopedics

Primary DI
00816847022545
Brand
VSP Orthopedics
Company
3D SYSTEMS, INC.
Model
Drill Guide (2.7mm and 6.5mm)
Device description
Reusable accessory drill guide
Published
2019-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PBFOrthopaedic Surgical Planning And Instrument Guides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBFOrthopaedic Surgical Planning And Instrument GuidesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190044000VSP Orthopedics System3D Systems, Inc.2019-08-21PBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816847022545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816847022545008168470225458168470225450816847022545

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
085049749
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816847022859VSP PEEKHost Skull Model2025-11-10
00816847022736Salto Talaris Flat Cut Total Ankle SystemTibia Cutting Guide2025-01-10
00816847022743Salto Talaris Flat Cut Total Ankle SystemTalus Cutting Guide2025-01-10
00816847022750Salto Talaris Flat Cut Total Ankle SystemAnatomical Model2025-01-10
00816847022767Cadence Flat Cut Total Ankle SystemTalus Cutting Guide2025-01-10
00816847022774Cadence Flat Cut Total Ankle SystemTibia Cutting Guide2025-01-10
00816847022781Cadence Flat Cut Total Ankle SystemAnatomical model2025-01-10
00816847022637Cadence Chamfer Cut Total Ankle SystemAnatomical model2024-09-12
00816847022651Salto Talaris Chamfer Cut Total Ankle SystemAnatomical Model2024-09-12
00816847022675VSP PEEKCranial Implant2024-09-12
00816847022699Salto Talaris Chamfer Cut Total Ankle SystemTalus Cutting Guide2024-09-12
00816847022705Salto Talaris Chamfer Cut Total Ankle SystemTibia Cutting Guide2024-09-12
00816847022712Cadence Chamfer Cut Total Ankle SystemTalus Cutting Guide2024-09-12
00816847022729Cadence Chamfer Cut Total Ankle SystemTibia Cutting Guide2024-09-12
00816847022798Vantage 3D PSITibia Cutting Guide2024-08-05
00816847022804Vantage 3D PSITalus Cutting Guide2024-08-05
00816847022811Vantage 3D PSIAnatomical Model2024-08-05
00816847022828Vantage 3D+ PSITibia Cutting Guide2024-08-05
00816847022835Vantage 3D+ PSITalus Cutting Guide2024-08-05
00816847022842Vantage 3D+ PSIAnatomical Model2024-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630345779939NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797063NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797070NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797087NextAR Spine Platform Medacta International SAPBF2023-07-24
G2710300240140IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240150IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240160IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240180IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240190IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240200IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240210IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240220IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240230IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240240IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240250IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260150IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260160IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260170IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260180IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260190IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260200IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260210IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260220IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260230IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260240IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260250IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310280150IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310280160IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310280170IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310280180IntelliguidesMios Marketing, LLCPBF2023-01-01