FDA.reportPublic FDA data

NA

Primary DI
00885556920053
Brand
NA
Company
Smith & Nephew, Inc.
Model
72205803
Catalog number
72205803
Device description
TESSA ACL FEM CURV KIT ENDOBUTTON 15
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
00885556920053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556920053008855569200538855569200530885556920053

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
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
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