FDA.reportPublic FDA data

OSTEORAPTOR / ULTRABRAID

Primary DI
03596010656315
Brand
OSTEORAPTOR / ULTRABRAID
Company
Smith & Nephew, Inc.
Model
72203289
Catalog number
72203289
Device description
OSTEORAPTOR CRVD 2.3MM 42 WHITE
Published
2015-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAIFASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAIFastener, Fixation, Biodegradable, 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
03596010656315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010656315035960106563153596010656315

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, bioabsorbableA bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
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

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Primary DI, Brand, Company table
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20845854655501Argo KnotlessConmed CorporationMAI2026-09-25
20653405990908GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990915GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990922GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990939GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990946GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990953GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
07290019361206OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-07-19
07290019361213OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-07-19
07290019361220OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-07-19
00888867304598Arthrex®ARTHREX, INC.MAI2026-07-08
00888867304604Arthrex®ARTHREX, INC.MAI2026-07-08
00888867304789Arthrex®ARTHREX, INC.MAI2026-07-08
00888867304796Arthrex®ARTHREX, INC.MAI2026-07-08
00816537023012FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023029FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023036FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023043FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023050FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023067FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023234FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00888867483927Arthrex®ARTHREX, INC.MAI2025-11-06
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHMAI2025-10-01
07613327662016KNOTILUS+STRYKER CORPORATIONMAI2025-06-16
07613327662030ALPHAVENTSTRYKER CORPORATIONMAI2025-06-16