FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BONE SOURCE HYDROXYAPATITE
K Number: K970400
·
Decision May 2, 1997
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
39
Applicant Total
57
Review Days
88
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Basic Information
- Device Name
- BONE SOURCE HYDROXYAPATITE
- K Number
- K970400
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3550
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthofix, Inc.
- Date Received
- February 3, 1997
- Decision Date
- May 2, 1997
- Product Code
- LZK
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LZK | Implant, Malar | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZK), ordered by most recent decision date.
AART MALAR IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PILLAR MALAR IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURGIFORM ANATOMICAL MALAR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SEARE BIOMEDICAL MALAR IMPLANTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SILIMED MALAR IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Orthofix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240749 | PILLAR SA Ti Spacer System (82-XXX) | May 28, 2024 | Substantially Equivalent |
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| K211710 | Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System | Jul 30, 2021 | Substantially Equivalent |
| K210667 | FIREBIRD SI Fusion System | Mar 25, 2021 | Substantially Equivalent |
| K203342 | CONSTRUX Mini Ti Spacer System | Mar 18, 2021 | Substantially Equivalent |
| K203576 | FORZA Ti Spacer System | Mar 3, 2021 | Substantially Equivalent |
| K203138 | FIREBIRD SI Fusion System | Nov 18, 2020 | Substantially Equivalent |
| K202949 | CONSTRUX Mini PEEK Spacer System | Oct 29, 2020 | Substantially Equivalent |
| K202666 | CONSTRUX Mini PTC Spacer System | Oct 14, 2020 | Substantially Equivalent |
| K201664 | FIREBIRD SI Fusion System | Sep 15, 2020 | Substantially Equivalent |