FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DANNINGER ORTHOPAEDIC AWL
K Number: K875223
·
Decision Feb 17, 1988
Classifications
1
FEI Numbers
325
Registration Numbers
325
Same Product Code
3
Applicant Total
6
Review Days
57
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Basic Information
- Device Name
- DANNINGER ORTHOPAEDIC AWL
- K Number
- K875223
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Danninger Medical Technology, Inc.
- Date Received
- December 22, 1987
- Decision Date
- February 17, 1988
- Product Code
- HWJ
- 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 |
|---|---|---|---|
| HWJ | Awl | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HWJ), ordered by most recent decision date.
CROSS MEDICAL PRODUCT PEDICLE AWL
FDA 510(k)
FDA Class 1
·Orthopedic
ACROMED AWL/PUNCH, DEPTH GAUGE
FDA 510(k)
FDA Class 1
·Orthopedic
ACROMED WALLIE-HEINIG TROCHAR
FDA 510(k)
FDA Class 1
·Orthopedic
Other Clearances by Danninger Medical Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931128 | BASIC SHOULDER CPM | May 6, 1994 | Substantially Equivalent |
| K933394 | DANNIFLEX CPM 600 | Mar 11, 1994 | Substantially Equivalent |
| K913026 | TTU-100THERMAL THERAPY UNIT | Dec 13, 1991 | Substantially Equivalent |
| K862730 | DANNIFLEX 400SL | Jul 24, 1986 | Substantially Equivalent |
| K844033 | MOBILIMB HAND UNIT | Nov 27, 1984 | Substantially Equivalent |