Affixus Tibial Nailing System - 4mm screws
Zimmer, Inc. · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Warsaw
- Advisory committee description
- Orthopedic
- Address 1
- 1800 W. Center St.
- Statement or summary
- Summary
- Product code
- HSB
- Zip code
- 46580
- Applicant
- Zimmer, Inc.
- Decision date
- 2025-02-12
- Decision code
- SESE
- Country code
- US
- Device name
- Affixus Tibial Nailing System - 4mm screws
- Advisory committee
- OR
- Contact
- Akash Savalia
- K number
- K243907
- State
- IN
- Date received
- 2024-12-19
- Review advisory committee
- OR
- Postal code
- 46580
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Rod, Fixation, Intramedullary And Accessories
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3020
- Device class
- 2
- Registration number
- 9617297, 3009455196, 3017521423, 3008868758, 1822565, 3014833750, 8043792, 3014302784, 3010287737, 3015876273, 3015877656, 3021008900, 3004450489, 1835572, 1226544, 9614438, 3008837339, 3007366790, 3008749819, 3008514120, 3006801265, 3025141, 3009381600, 3010364775, 3015212339, 3007993775, 1644408, 3007125392, 3013302242, 3016727307, 3006742481, 2134285, 3012392319, 3014527928, 3006846753, 3000327445, 3030412764, 3011388423, 3003477135, 3015216945 +265 more
- FEI number
- 3009455196, 3000718490, 3017521423, 3008868758, 3014833750, 3015876273, 3014302784, 3010287737, 3015877656, 3021008900, 3004450489, 3002807036, 3008837339, 3008749819, 3008514120, 3006801265, 3009381600, 3010364775, 3015212339, 3007993775, 1000139987, 3002808269, 3007125392, 3013302242, 3016727307, 3006742481, 1000306303, 3012392319, 3003414678, 3007282753, 3014527928, 3006846753, 3002807231, 3000327445, 3003015552, 3030412764, 3011388423, 3003477135, 3015216945, 3026593233 +265 more