Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures
Arthrex, Inc. · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Naples
- Advisory committee description
- Orthopedic
- Address 1
- 1370 Creekside Blvd.
- Statement or summary
- Summary
- Product code
- JDQ
- Zip code
- 34108
- Applicant
- Arthrex, Inc.
- Decision date
- 2025-02-20
- Decision code
- SESE
- Country code
- US
- Device name
- Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures
- Advisory committee
- OR
- Contact
- Emmarie Halteman
- K number
- K243344
- State
- FL
- Date received
- 2024-10-25
- Review advisory committee
- OR
- Postal code
- 34108
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Cerclage, Fixation
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3010
- Device class
- 2
- Registration number
- 3008556682, 9610612, 3018094310, 3008868758, 1822565, 3002579136, 8043792, 3013011598, 3015876273, 3014302784, 3021008900, 1226544, 3007366790, 3006801265, 3025141, 3005180920, 3008974316, 3013302242, 3006946276, 3016727307, 2134285, 3030412764, 3010155648, 3008114965, 3003477135, 3015806723, 2953359, 3033509898, 3008812560, 3006017180, 3012329552, 3017528621, 3003761012, 3010400367, 3021226419, 3011230048, 1833986, 3011295718, 3016050940, 3013756169 +115 more
- FEI number
- 3008556682, 1000477302, 3018094310, 3008868758, 3002579136, 3015876273, 3013011598, 3014302784, 3021008900, 3002807036, 3002993297, 3006801265, 3005180920, 3003058119, 1000139987, 3002808269, 3008974316, 3013302242, 3006946276, 3016727307, 1000306303, 3002807172, 3007282753, 3003015552, 3030412764, 3010155648, 3008114965, 3003477135, 3015806723, 3033509898, 3008812560, 3006017180, 3012329552, 3017528621, 3003761012, 3010400367, 3021226419, 3011230048, 3011295718, 3002287318 +115 more