FDA.reportPublic FDA data

DISCOVERY

Primary DI
10705034034553
Brand
DISCOVERY
Company
DEPUY SPINE, LLC
Model
175703020
Catalog number
175703020
Device description
DISCOVERY SCREW SYSTEM CANNULATED FACET SCREW 4.0 x 20mm
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRWSYSTEM, FACET SCREW SPINAL DEVICE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRWSystem, Facet Screw Spinal DeviceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012773000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012773000DISCOVERY FACET SCREW FIXATION SYSTEMDepuyacromed2001-11-16MRW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034034553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503403455310705034034553

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
107105876
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034245973CONDUIT2761-01-0152761010152015-09-24
10705034245980CONDUIT2761-01-0102761010102015-09-24
10705034245997CONDUIT2761-01-0052761010052015-09-24
10705034245966CONDUIT2761-01-0302761010302015-09-24
10705034604572CROSSNAV3020-20-0012025-02-14
10705034471716N/A6983411716983411712022-10-07
10705034570105N\A6983447336983447332022-10-07
10705034570211N/A6983447246983447242022-10-07
10705034570228N\A6983447346983447342022-10-07
10705034570433N/A6983447266983447262022-10-07
10705034570501N\A6983447326983447322022-10-07
10705034570624N/A6983447286983447282022-10-07
10705034570693N\A6983447316983447312022-10-07
10705034570723N/A6983447276983447272022-10-07
10705034458267N/A6983393806983393802022-02-02
10705034137049BENGAL1873011131873011132015-09-24
10705034137056BENGAL1873011141873011142015-09-24
10705034137063BENGAL1873011151873011152015-09-24
10705034137070BENGAL1873011161873011162015-09-24
10705034585321TRIALTIS Spine System5560-12-4560FS5560124560FS2026-05-18

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Primary DI, Brand, Company table
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00888867614581Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614598Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614604Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614611Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614628Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614635Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614642Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614659Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614666Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614673Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614680Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614697Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614703Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614710Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614727Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614734Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614741Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614758Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614765Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614772Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614789Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614796Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614802Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614819Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614826Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614833Arthrex®ARTHREX, INC.MRW2026-10-07