NA

Primary DI
00885556924464
Brand
NA
Company
Smith & Nephew, Inc.
Model
72205785
Catalog number
72205785
Device description
LICENSE FOR IMAGE CTR ONLY
Published
2026-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
SIQIntra-articular orthopedic stereotaxic navigation instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SIQIntra-articular orthopedic stereotaxic navigation instrument

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN250037000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN250037000TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc.2026-07-06SIQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556924464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556924464008855569244648855569244640885556924464

GMDN Terms#

Term, Definition table
TermDefinition
Surgical planning/navigation-enhancement systemA mobile assembly of mains electricity (AC-powered) devices intended for both pre- and intraoperative applications to: 1) process medical imaging data to create a patient-specific, three-dimensional (3-D) model to enable a surgeon to plan/prepare for a surgical procedure; and 2) connect to a separate surgical navigation system to extract and display real-time surgical navigation information (e.g., navigation pointer) within the same 3-D model during surgery. It includes hardware [e.g., personal computer (PC), monitors, medical grade keyboard) and dedicated software. It is capable of collecting patient demographics, which may be anonymised.

Contacts#

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

Regulatory Flags#

DUNS number
045483575
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00885556926680TESSA72205786722057862026-08-14
00885556926703TESSA72205787722057872026-08-14
00885556922170NA74034437740344372026-07-31
00885556925171REAL INTELLIGENCEROB100021FROB100021F2026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556918937NASmith & Nephew, Inc.SIQ2026-08-19
00885556918968NASmith & Nephew, Inc.SIQ2026-08-19
00885556919897NASmith & Nephew, Inc.SIQ2026-08-19
00885556919965NASmith & Nephew, Inc.SIQ2026-08-19
00885556919972NASmith & Nephew, Inc.SIQ2026-08-19
00885556919989NASmith & Nephew, Inc.SIQ2026-08-19
00885556919996NASmith & Nephew, Inc.SIQ2026-08-19
00885556920008NASmith & Nephew, Inc.SIQ2026-08-19
00885556920015NASmith & Nephew, Inc.SIQ2026-08-19
00885556920022NASmith & Nephew, Inc.SIQ2026-08-19
00885556920039NASmith & Nephew, Inc.SIQ2026-08-19
00885556920046NASmith & Nephew, Inc.SIQ2026-08-19
00885556920053NASmith & Nephew, Inc.SIQ2026-08-19
00885556924433TESSA ACL FEM LIC NO CLOUDSmith & Nephew, Inc.SIQ2026-08-14
00885556924440TESSASmith & Nephew, Inc.SIQ2026-08-14
00885556924457TESSASmith & Nephew, Inc.SIQ2026-08-14
00885556926680TESSASmith & Nephew, Inc.SIQ2026-08-14
00885556926703TESSASmith & Nephew, Inc.SIQ2026-08-14