FDA.reportPublic FDA data

NA

Primary DI
00885554028041
Brand
NA
Company
Smith & Nephew, Inc.
Model
72203460
Catalog number
72203460
Device description
FLEXIBLE OBTURATOR FOR 2.3 MM CURVED GUIDE AND SUTURE ANCHOR DELIVERY SYSTEM, TROCAR TIP
Published
2015-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDRSTAPLE, FIXATION, BONE
MBIFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103309000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103309000OSTEORAPTOR CURVED 2.3 SUTURE ANCHORSSmith & Nephew Endoscopy, Inc.2011-02-03MAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885554028041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885554028041008855540280418855540280410885554028041

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide obturatorA surgical device designed to fill the lumen of a drill guide during its insertion to a surgical site primarily to prevent tissue obstruction of the drill guide lumen. When the drill guide is firmly placed at the chosen position on the bone surface, the obturator is removed. It is typically a rod with a rounded distal end, which protrudes out of the drill guide, and a knob-like handle that functions as a regulator to control the length of the protruding end and to remove it from the drill guide. It is typically made of a high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556919781Real IntelligenceROB30007ROB300072026-10-13
00885556924327Real IntelligenceROB30801ROB308012026-10-08
03596010445803NA720903072090302015-08-30
03596010470294SAPHYRE720968472096842015-08-30
03596010470331ABLATOR720965972096592015-08-30
03596010470348ABLATOR720965872096582015-08-30
03596010470416ABLATOR720965172096512015-08-30
03596010470577ABLATOR720965072096502015-08-30
03596010470614TAC-S720963272096322015-08-30
03596010448446TWINFIX720910972091092015-08-30
03596010470393ABLATOR720965372096532015-08-30
03596010470423ABLATOR720964972096492015-08-30
03596010510976NA721004072100402015-08-30
00885556236949STRUCSURE7178057178052016-04-08
00885556236994STRUCSURE7178087178082016-04-08
00885556237045STRUCSURE7178167178162016-04-08
00885556838211Total Foot System 2280500728050072023-04-18
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00888867627857Arthrex®ARTHREX, INC.MBI2026-10-07
00888867627864Arthrex®ARTHREX, INC.MBI2026-10-07
00817337000586Integrity Retractable Implant InserterAnika Therapeutics, Inc.MBI2026-10-05
00860013918606ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00888867520745Arthrex®ARTHREX, INC.MBI2026-01-21
00840277407962JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277407979JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277407986JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277407993JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277408006JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277408013JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277408020JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277407955JuggerKnotless Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-07-29
07613327662030ALPHAVENTSTRYKER CORPORATIONMBI2025-06-16
07613327662047ALPHAVENTSTRYKER CORPORATIONMBI2025-06-16
07613327662054ALPHAVENTSTRYKER CORPORATIONMBI2025-06-16
00840277405012OC JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405029OC JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405036OC JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405043OC JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405050OC JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405067OC JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405074OC JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405081OC JuggerLoop™ Soft Anchor SPRIVERPOINT MEDICAL, LLCMBI2024-12-19
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