FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM
K Number: K083311
·
Decision Mar 4, 2009
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
22
Review Days
114
Basic Information
- Device Name
- AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM
- K Number
- K083311
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aesculap Implant Systems, Inc.
- Date Received
- November 10, 2008
- Decision Date
- March 4, 2009
- Product Code
- ODP
- 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 |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K123352 | S4 SPINAL SYSTEM | Dec 12, 2012 | Substantially Equivalent |
| K111122 | AESCULAP SIBD XP SPINAL SYSTEM | Aug 4, 2011 | Substantially Equivalent |
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| K083495 | MODIFICATION TO: METHA HIP SYSTEM | Jan 15, 2009 | Substantially Equivalent |