FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROTORBLADE SUTURE ANCHOR
K Number: K993373
·
Decision Oct 27, 1999
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
219
Applicant Total
17
Review Days
20
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Basic Information
- Device Name
- ROTORBLADE SUTURE ANCHOR
- K Number
- K993373
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Li Medical Technologies, Inc.
- Date Received
- October 7, 1999
- Decision Date
- October 27, 1999
- Product Code
- MAI
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | FDA class 2 | Orthopedic |
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Other Clearances by Li Medical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002413 | ULTRASORB SUTURE ANCHOR | Sep 19, 2000 | Substantially Equivalent |
| K992938 | ROTORBLADE SUTURE ANCHOR | Sep 23, 1999 | Substantially Equivalent |
| K983435 | ROTORBLADE | Apr 29, 1999 | Substantially Equivalent |
| K981755 | LM ANCHOR | Jul 13, 1998 | Substantially Equivalent |
| K981764 | LM ANCHOR | Jul 13, 1998 | Substantially Equivalent |
| K963288 | LM BONE ANCHOR | Nov 13, 1996 | Substantially Equivalent |
| K963812 | LM BONE ANCHOR (ORTHOPEDICS) | Nov 12, 1996 | Substantially Equivalent |
| K960825 | LM ANCHOR OR OTHER PROPRIETARY NAME | Apr 30, 1996 | Substantially Equivalent |
| K960439 | LM BONE ANCHOR | Apr 18, 1996 | Substantially Equivalent |
| K960448 | LM ANCHOR | Apr 17, 1996 | Substantially Equivalent |