510(k) K873507
K873507 is an FDA 510(k) premarket notification submitted by Link America, Inc. for the device "LINK (R) AMERICAN-TYPE BONE STAPLE SYSTEM". The FDA issued a decision of Substantially Equivalent on September 16, 1987. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Link America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 1987
- Date Received
- August 31, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type