Product code HTP
- Device name
- File
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4540
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K931733 | INTERMEDICS ORTHOPEDICS REAMERS | Intermedics Orthopedics | 1994-01-26 |
| K870842 | SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP | Warsaw Orthopedic, Inc. | 1987-05-27 |
| K862659 | CONCEPT ARTHROSCOPY RASP | Concept, Inc. | 1986-09-02 |
| K841981 | 4MM & 5MM FILE | Stainless Mfg., Inc. | 1984-06-19 |
| K840492 | SUN-LITE BLUE SLIT | Suncoast Medical Manufacturers, Inc. | 1984-05-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10810128463574 | Rasp Up Bend 20° | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2026-05-13 |
| 10810128463581 | Rasp Down Bend 20° | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2026-05-13 |
| 04047844052501 | INSTRUMENT | SIGNUS Medizintechnik GmbH | 2025-06-04 |
| 04047844058442 | INSTRUMENT | SIGNUS Medizintechnik GmbH | 2025-05-05 |
| 04047844058596 | RABEA | SIGNUS Medizintechnik GmbH | 2025-03-12 |
| 04047844058589 | RABEA | SIGNUS Medizintechnik GmbH | 2025-03-12 |
| 04047844058572 | RABEA | SIGNUS Medizintechnik GmbH | 2025-03-12 |
| 04047844058565 | RABEA | SIGNUS Medizintechnik GmbH | 2025-03-12 |
| 04047844058558 | RABEA | SIGNUS Medizintechnik GmbH | 2025-03-12 |
| 04047844055007 | NUBIC | SIGNUS Medizintechnik GmbH | 2025-03-10 |
| 04047844055076 | NUBIC | SIGNUS Medizintechnik GmbH | 2025-03-10 |
| 04047844055069 | NUBIC | SIGNUS Medizintechnik GmbH | 2025-03-10 |
| 04047844055052 | NUBIC | SIGNUS Medizintechnik GmbH | 2025-03-10 |
| 04047844055045 | NUBIC | SIGNUS Medizintechnik GmbH | 2025-03-10 |
| 04047844055038 | NUBIC | SIGNUS Medizintechnik GmbH | 2025-03-10 |
| 04047844055021 | NUBIC | SIGNUS Medizintechnik GmbH | 2025-03-10 |
| 04047844055014 | NUBIC | SIGNUS Medizintechnik GmbH | 2025-03-10 |
| 04047844054994 | NUBIC | SIGNUS Medizintechnik GmbH | 2025-03-10 |
| 04047844054987 | NUBIC | SIGNUS Medizintechnik GmbH | 2025-03-10 |
| 10810128461297 | VersiTomic Meniscal Rasp, Ball, 90 | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2025-02-10 |
| 10810128461280 | VersiTomic Meniscal Rasp, Ball, 45 | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2025-02-10 |
| 14026704799104 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
| 04047844055663 | INSTRUMENT | SIGNUS Medizintechnik GmbH | 2022-06-21 |
| 04047844052495 | INSTRUMENT | SIGNUS Medizintechnik GmbH | 2022-06-20 |
| 04047844052471 | INSTRUMENT | SIGNUS Medizintechnik GmbH | 2022-06-20 |
| 10381780456193 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780427216 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-10 |
| M6842251BF00001 | Axiom | Microport Orthopedics Inc. | 2017-03-09 |
| 00889024449602 | Natural-Knee® | Zimmer, Inc. | 2017-02-17 |
| 10810190016432 | PCL Liberator/Rasp | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |