FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRASORB SUTURE ANCHOR
K Number: K002413
·
Decision Sep 19, 2000
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
219
Applicant Total
17
Review Days
43
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ULTRASORB SUTURE ANCHOR
- K Number
- K002413
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Li Medical Technologies, Inc.
- Date Received
- August 7, 2000
- Decision Date
- September 19, 2000
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MAI), ordered by most recent decision date.
Arthrex Bioabsorbable PushLock Suture Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
SF Push-in Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
OSSIOfiber® Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
Biosteon® Screw
FDA 510(k)
FDA Class 2
·Orthopedic
BioBrace® Extra-Articular Ligament Augmentation Kit
FDA 510(k)
FDA Class 2
·Orthopedic
OSSIOfiber® Interference Screw
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Li Medical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K960448 | LM ANCHOR | Apr 17, 1996 | Substantially Equivalent |