FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250
K Number: K993610
·
Decision Mar 2, 2000
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
8
Review Days
129
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Basic Information
- Device Name
- CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250
- K Number
- K993610
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteogenics Biomedical, Inc.
- Date Received
- October 25, 1999
- Decision Date
- March 2, 2000
- Product Code
- LYC
- 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 |
|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | FDA class 2 | Dental |
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|---|---|---|---|
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| K093719 | PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# | Mar 1, 2010 | Substantially Equivalent |
| K072076 | CYTOPLAST PTFE SUTURE | Oct 31, 2007 | Substantially Equivalent |
| K013764 | IMMIX BONE GRAFT EXTENDER | May 16, 2002 | Substantially Equivalent |
| K003028 | CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC | Nov 24, 2000 | Substantially Equivalent |
| K984230 | OSTEO-MESH TM-300 | Feb 4, 1999 | Substantially Equivalent |