FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Intra-Lock Bone Fixation System
K Number: K171831
·
Decision Oct 26, 2017
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
79
Applicant Total
5
Review Days
128
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Basic Information
- Device Name
- Intra-Lock Bone Fixation System
- K Number
- K171831
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4880
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intra-Lock International, Inc.
- Date Received
- June 20, 2017
- Decision Date
- October 26, 2017
- Product Code
- DZL
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| DZL | Screw, Fixation, Intraosseous | FDA class 2 | Dental |
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Other Clearances by Intra-Lock International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K133613 | INTRA-LOCK DENTAL IMPLANTS | Mar 20, 2014 | Substantially Equivalent |
| K111199 | INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS | Aug 8, 2011 | Substantially Equivalent |
| K103194 | INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM | Apr 21, 2011 | Substantially Equivalent |
| K082419 | REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1 | May 27, 2009 | Substantially Equivalent |