SD Trans-Osseous Fastener Models Tob 6 Bolt 32/50, Tob 6 Bolt 50/80, Tob 6 Bolt 80/140, Tob 6 Washer Models 12MM 16MM 1M
FDA 510(k) K982354 · Special Devices, Inc.
510(k) numberK982354
Submission
- Device name
- SD Trans-Osseous Fastener Models Tob 6 Bolt 32/50, Tob 6 Bolt 50/80, Tob 6 Bolt 80/140, Tob 6 Washer Models 12MM 16MM 1M
- Applicant
- Special Devices, Inc.
Grass Valley, CA, US - Received
- July 6, 1998
- Decision date
- November 23, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HTN – Washer, Bolt Nut
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was SD Trans-Osseous Fastener Models Tob 6 Bolt 32/50, Tob 6 Bolt 50/80, Tob 6 Bolt 80/140, Tob 6 Washer Models 12MM 16MM 1M cleared by the FDA?
SD Trans-Osseous Fastener Models Tob 6 Bolt 32/50, Tob 6 Bolt 50/80, Tob 6 Bolt 80/140, Tob 6 Washer Models 12MM 16MM 1M (K982354) received a 510(k) decision of Substantially Equivalent on November 23, 1998, 140 days after the submission was received.
What is the product code of K982354?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.