FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXCIA TOTAL HIP SYSTEM LATERAL OFFSET
K Number: K061344
·
Decision Aug 2, 2006
Classifications
1
FEI Numbers
227
Registration Numbers
227
Same Product Code
562
Applicant Total
207
Review Days
79
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EXCIA TOTAL HIP SYSTEM LATERAL OFFSET
- K Number
- K061344
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aesculap, Inc.
- Date Received
- May 15, 2006
- Decision Date
- August 2, 2006
- Product Code
- JDI
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDI), ordered by most recent decision date.
Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head
FDA 510(k)
FDA Class 2
·Orthopedic
Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners
FDA 510(k)
FDA Class 2
·Orthopedic
Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
FDA 510(k)
FDA Class 2
·Orthopedic
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
FDA 510(k)
FDA Class 2
·Orthopedic
Stryker Orthopaedics Hip Systems Labeling Update
FDA 510(k)
FDA Class 2
·Orthopedic
Global Modular Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Aesculap, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K242762 | Aesculap Aicon® Series Container System | May 13, 2025 | Substantially Equivalent |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set | Dec 16, 2024 | Substantially Equivalent |
| K223596 | SQ.line KERRISON | Jun 29, 2023 | Substantially Equivalent |
| K214041 | Aesculap AICON Container | Dec 30, 2022 | Substantially Equivalent |
| K211572 | Aesculap Slim Clip Applier | Dec 13, 2021 | Substantially Equivalent |
| K203739 | ELAN 4 Electro Motor System | Aug 24, 2021 | Substantially Equivalent |
| K202391 | DIR 800 | Jan 21, 2021 | Substantially Equivalent |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology System | Dec 18, 2020 | Substantially Equivalent |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology System | Oct 30, 2020 | Substantially Equivalent |
| K202124 | Aesculap PAS-Port Proximal Anastomosis System | Sep 2, 2020 | Substantially Equivalent |