Origin Cemented Hip Stem
Signature Orthopaedics Pty, Ltd. · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Lane Cove West
- Advisory committee description
- Orthopedic
- Address 1
- 7 Sirius Rd.
- Statement or summary
- Summary
- Product code
- LZO
- Zip code
- 2066
- Applicant
- Signature Orthopaedics Pty, Ltd.
- Decision date
- 2025-05-02
- Decision code
- SESE
- Country code
- AU
- Device name
- Origin Cemented Hip Stem
- Advisory committee
- OR
- Contact
- Declan Brazil
- K number
- K243043
- Date received
- 2024-09-27
- Review advisory committee
- OR
- Postal code
- 2066
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3353
- Device class
- 2
- Registration number
- 3014272734, 3010047454, 3020967480, 3013450937, 1833506, 1836357, 1000200989, 1226544, 3027484613, 1038671, 3009871135, 3004188066, 3013302242, 1828464, 1220477, 3007391088, 3015167917, 3012916784, 3000264985, 3012119238, 3010163695, 3015516266, 3007353762, 3002807408, 3009882462, 3006801265, 3010386387, 3004153240, 3007120646, 3004513872, 3011274144, 3015259876, 3003639920, 9616680, 2249697, 3009475821, 3008668801, 3000196378, 3013194153, 2648920 +239 more
- FEI number
- 3002806315, 3002807479, 3014272734, 3010047454, 3020967480, 3013450937, 1000200989, 3027484613, 1038671, 3009871135, 3004188066, 3013302242, 1000115656, 3003110073, 1220477, 1828464, 3001236277, 3003574398, 3007282753, 3007391088, 1000135253, 3015167917, 3012916784, 3008397795, 3000264985, 3012119238, 3010163695, 3015516266, 3007353762, 3002807408, 3009882462, 3006801265, 3010386387, 3004153240, 3007120646, 3002807113, 3004513872, 3011274144, 3015259876, 3003639920 +239 more