ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50
FDA 510(k) clearance K041451 · decided 2004-08-25
Clearance details
- K-number
- K041451
- Device name
- ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50
- Applicant
- Ascension Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-06-01
- Decision date
- 2004-08-25
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- KYI
- Device class
- 2
- Regulation number
- 888.3770
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The Ascension PyroHemiSphere (aka NuGrip), Model #30-L NUG-443-30L, Catalog #NUG-443-30L, recall (Z-0437-2011) | Ascension Orthopedics, Inc | 2010-11-22 |
| The Ascension PyroHemiSphere (aka NuGrip), Model #40-M NUG-443-40M, Catalog #NUG-443-40M, recall (Z-0438-2011) | Ascension Orthopedics, Inc | 2010-11-22 |