FDA.reportPublic FDA data

NA

Primary DI
00885556909331
Brand
NA
Company
Smith & Nephew, Inc.
Model
52858-02
Catalog number
52858-02
Device description
Starlock - Interface
Published
2025-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193307000HIP7Brainlab AG2020-06-02OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556909331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556909331008855569093318855569093310885556909331

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556918937NA72205810722058102026-08-19
00885556918968NA72205911722059112026-08-19
00885556919897NA72205802722058022026-08-19
00885556919965NA72205777722057772026-08-19
00885556919972NA72205778722057782026-08-19
00885556919989NA72205790722057902026-08-19
00885556919996NA72205791722057912026-08-19
00885556920008NA72205792722057922026-08-19
00885556920015NA72205793722057932026-08-19
00885556920022NA72205800722058002026-08-19
00885556920039NA72205801722058012026-08-19
00885556920046NA72205782722057822026-08-19
00885556920053NA72205803722058032026-08-19
00885556924433TESSA ACL FEM LIC NO CLOUD72205781722057812026-08-14
00885556924440TESSA72205783722057832026-08-14
00885556924457TESSA72205784722057842026-08-14
00885556924464NA72205785722057852026-08-14
00885556926680TESSA72205786722057862026-08-14
00885556926703TESSA72205787722057872026-08-14
00885556922170NA74034437740344372026-07-31

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Primary DI, Brand, Company table
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00840493426433RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426440RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426457RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426464RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426471RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426488RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426495RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426501RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426518RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426525RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426532RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426549RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426556RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426563RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426570RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426587RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426594RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426600RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426617RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426624RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426631RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
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00763000995195Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-08-14
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