FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HAMMERLOCK
K Number: K091951
·
Decision Feb 19, 2010
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
200
Applicant Total
13
Review Days
233
Basic Information
- Device Name
- HAMMERLOCK
- K Number
- K091951
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIOMEDICAL ENT., INC.
- Date Received
- July 1, 2009
- Decision Date
- February 19, 2010
- Product Code
- HTY
- 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 |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | FDA class 2 | Orthopedic |
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Other Clearances by BIOMEDICAL ENT., INC.
| K Number | Device Name | ||
|---|---|---|---|
| K133844 | SPEED TRIAD | Apr 7, 2014 | Substantially Equivalent |
| K133780 | SPEED XL | Mar 19, 2014 | Substantially Equivalent |
| K131640 | SMOOTH OR THREADED METALLIC BONE FASTENER | Oct 16, 2013 | Substantially Equivalent |
| K102107 | OSSTAPLE CHILL | Sep 3, 2010 | Substantially Equivalent |
| K023203 | OSSTAPLE | Oct 17, 2002 | Substantially Equivalent |
| K001353 | MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM | Mar 13, 2001 | Substantially Equivalent |
| K001354 | MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM | Mar 13, 2001 | Substantially Equivalent |
| K001219 | MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM | Jun 21, 2000 | Substantially Equivalent |
| K993714 | MEMOGRAPH STAPLE, WARM SYSTEM | Feb 25, 2000 | Substantially Equivalent |
| K971782 | BONE AND MARROW COLLECTION SYSTEM KIT | Jul 29, 1997 | Substantially Equivalent |