AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE
FDA 510(k) clearance K071983 · decided 2008-05-01
Clearance details
- K-number
- K071983
- Device name
- AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE
- Applicant
- Aesculap Implant Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-07-19
- Decision date
- 2008-05-01
- Days to decision
- 287 days
- Clearance type
- Traditional
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body rep recall (Z-1806-2013) | Aesculap, Inc. | 2013-07-25 |