TESSA ACL FEM LIC NO CLOUD

Primary DI
00885556924433
Brand
TESSA ACL FEM LIC NO CLOUD
Company
Smith & Nephew, Inc.
Model
72205781
Catalog number
72205781
Device description
TESSA ACL FEM LIC SW NO CLOUD
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
00885556924433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556924433008855569244338855569244330885556924433

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
00885556819845Uni-CP Compression Plate286322ND286322ND2023-11-07
00885556819852Uni-CP Compression Plate286324ND286324ND2023-11-07
00885556819869Uni-CP Compression Plate286326ND286326ND2023-11-07
00885556819876Uni-CP Compression Plate286328ND286328ND2023-11-07
00885556819883Uni-CP Compression Plate286330ND286330ND2023-11-07
00885556819890Uni-CP Compression Plate286332ND286332ND2023-11-07
00885556819906Uni-CP Compression Plate286334ND286334ND2023-11-07
00885556819357General Instruments219865ND219865ND2023-10-27
00885556846599Total Wrist Fusion186200ND186200ND2023-10-27
00885556910245UNI-CP Compression Plate186300ND186300ND2023-10-27
00885556819722Total Wrist Fusion286220ND286220ND2023-10-26
00885556819746Total Wrist Fusion286222ND286222ND2023-10-26
00885556819760Total Wrist Fusion286224ND286224ND2023-10-26
00885556819807UNI-CP Compression Plate286314ND286314ND2023-10-26
00885556819814UNI-CP Compression Plate286316ND286316ND2023-10-26
00885556819821UNI-CP Compression Plate286318ND286318ND2023-10-26
00885556819838UNI-CP Compression Plate286320ND286320ND2023-10-26
00885556847329UNI-CP Compression Plate219535ND219535ND2023-10-26
00885556819623Total Wrist Fusion286210ND286210ND2023-10-25
00885556819647SURFIXTotal Wrist Fusion286212ND286212ND2023-10-25

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
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