FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACUMED SUTURE WASHER
K Number: K965028
·
Decision Mar 17, 1997
Classifications
1
FEI Numbers
272
Registration Numbers
272
Same Product Code
92
Applicant Total
43
Review Days
90
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
- ACUMED SUTURE WASHER
- K Number
- K965028
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acu Med, Inc.
- Date Received
- December 17, 1996
- Decision Date
- March 17, 1997
- Product Code
- HTN
- 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 |
|---|---|---|---|
| HTN | Washer, Bolt Nut | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HTN), ordered by most recent decision date.
LARS ACJ
FDA 510(k)
FDA Class 2
·Orthopedic
SportLinc Syndesmosis Device
FDA 510(k)
FDA Class 2
·Orthopedic
Syndesmosis TightRope PRO
FDA 510(k)
FDA Class 2
·Orthopedic
Synchfix EVT
FDA 510(k)
FDA Class 2
·Orthopedic
RipCord
FDA 510(k)
FDA Class 2
·Orthopedic
Acu-Sinch Knotless Mini
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Acu Med, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021321 | WRIST FUSION PLATE | Jul 17, 2002 | Substantially Equivalent |
| K013616 | POLARUS CAP SCREW | Dec 19, 2001 | Substantially Equivalent |
| K012655 | CONGRUENT BONE PLATE SYSTEM | Nov 7, 2001 | Substantially Equivalent |
| K992525 | ACUMED MODULAR SHOULDER SYSTEM | Feb 4, 2000 | Substantially Equivalent |
| K993657 | ACUMED SUTURE ANCHOR | Jan 13, 2000 | Substantially Equivalent |
| K980103 | ACUMED SUTURE ANCHOR | Mar 16, 1998 | Substantially Equivalent |
| K965029 | STABLELOC II EXTERNAL FIXATOR | Feb 19, 1997 | Substantially Equivalent |
| K964500 | ACUMED TENSION BAND PIN | Dec 9, 1996 | Substantially Equivalent |
| K963026 | TBD | Oct 28, 1996 | Substantially Equivalent |
| K963118 | EXTREMITY BONE SCREW | Oct 10, 1996 | Substantially Equivalent for Some Indications |