Hyper-C 02-12P
Hyper-C 02-12P is a bone tack inserter (FDA Class I; FDA product code LXH, Orthopedic manual surgical instrument) made by Degen Medical, listed in FDA GUDID since 22 Aug 2022 (UDI-DI 00842048152156), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00842048152156 | Date22 Aug 2022 | StatusListed |
Official records
- AccessGUDID record 00842048152156
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Hyper-C
- Generic name
- Bone tack inserter, basic
- Model / Ref / Catalog
- 02-12P
- Primary DI / UDI-DI
- 00842048152156
- FDA product code
- LXH
- GMDN term
- Bone tack inserter, basic
- Device class
- Class I
- Regulation number
- 888.4540
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices
Other devices filed under FDA product code LXH (Orthopedic manual surgical instrument).
- HIP Instruments 01.22.10.0667 by Medacta International SA
- Hip Instruments I05.0068 by Medacta International SA
- Oxford® Partial Knee System 32-420660 by Biomet Uk Ltd
- YUKON OCT Spinal System 7601-90075 by VB Spine LLC
- 2255-08-01 00-2255-008-01 by Zimmer, Inc.
- AGK16100 by Stryker GmbH
- Orthopaedic Surgical Instruments Dolphix calcaneal distractor Kit DF900100 by Citieffe
- ACUMED HRDL020 by ACUMED LLC
- INTRAFIX 254842 by MEDOS INTERNATIONAL SARL
- CHISEL OSTEOTOME BLADE 127x12 WITH HOLE H0050208509 by HPF SRL