FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LMT BONE ANCHOR
K Number: K953764
·
Decision Aug 25, 1995
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
230
Applicant Total
17
Review Days
14
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Basic Information
- Device Name
- LMT BONE ANCHOR
- K Number
- K953764
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Li Medical Technologies, Inc.
- Date Received
- August 11, 1995
- Decision Date
- August 25, 1995
- Product Code
- JDR
- 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 |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | 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 |
| K993373 | ROTORBLADE SUTURE ANCHOR | Oct 27, 1999 | 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 |