NA

Primary DI
00885556919989
Brand
NA
Company
Smith & Nephew, Inc.
Model
72205790
Catalog number
72205790
Device description
TESSA ACL Femur Straight Aimer Kit with ULTRABUTTON Adjustable Fixation Device
Published
2026-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
00885556919989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556919989008855569199898855569199890885556919989

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during orthopaedic surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

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
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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
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
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
00885556924464NASmith & Nephew, Inc.SIQ2026-08-14
00885556926680TESSASmith & Nephew, Inc.SIQ2026-08-14
00885556926703TESSASmith & Nephew, Inc.SIQ2026-08-14