Medical Device Division · registration 160470ActiveK2M
Hong KongProsthesis Implantation Instruments, OrthopedicClass IIK2M, Inc.
Official record identity
- MDACS listing number
- 160470
- Model name
- Interbody Access System (1501-90005, 1501-90006, 1501-90007, 1501-90008, 1501-90009, 1501-90010, 1501-90011, 1501-90012, 1501-90013, 1501-90014, 1501-90015, 1501-90016, 1501-90017, 1501-90018, 1501-90019, 1501-90020, 1501-90021, 1501-90026, 1501-90027, 1501-90028, 1501-90029, 1501-90030, 1501-90031, 1501-90032, 1501-90033, 1501-90035, 1501-90037, 1501-90039, 1501-90041, 1501-90045, 1501-90055, 2701-90000, 2701-90001, 2701-90002, 2701-90003, 2701-90004, 2701-90005, 2701-90006, 2701-90007, 2701-90010, 2701-90011, 2701-90012, 2701-90013, 2701-90014, 2701-90015, 2701-90016, 2701-90017, 2701-90028, 2701-90029, 2701-90030, 2701-90031, 2701-90032, 2701-90033, 2701-90034, 2701-90035, 2701-90036, 2701-90037, 2701-90038, 2701-90039, 2701-90040, 2701-90041, 2701-90042, 2701-90043, 2701-90044, 2701-90045, 2701-90046, 2701-90047, 2701-90048, 2701-90049, 2701-90050, 2701-90051, 2701-90052, 2701-90053, 2701-90054, 2701-90055, 2701-90056, 2701-90057, 2701-90058, 2701-90059, 2701-90060, 2701-90061, 2701-90062, 2701-90063, 2701-90064, 2701-90065, 2701-90066, 2701-90067, 2701-90068, 2701-90069, 2701-90072, 2701-90073, 2701-90074, 2701-90075, 2701-90076, 2701-90077, 2701-90078, 2701-90079, 2701-90080, 2701-90081, 2701-90082, 2701-90083, 2701-90084, 2701-90085, 2701-90086, 2701-90089, 2701-90091, 2701-90092, 2701-90094, 2701-90095, 2701-90096, 2701-90097, 2701-90098, 2701-90099, 2701-90100, 2701-90101, 2701-90102, 2701-90103, 2701-90104, 2701-90105, 2701-90106, 2701-90110, 2701-90133, 705-1010-3, 714-1100-0, 714-1100-0D, 714-1100-1, 714-1100-1U, 714-1102-0, 714-1102-0D, 714-1102-1, 714-1102-1U, 714-1120-2D, 714-1130-0, 714-1130-0D, 714-1130-1, 714-1130-1U, 722-1154-3, 725-1115-3, 725-1154-3, 746-1120-3, 746-1250-1, 801-0700-0, 837-0902-0, 837-0903-0, 837-0904-0, 837-0912-0, 837-0912-1, 837-0914-0, 837-0914-1, K2-27-2001-01, K2-27-2001-02, K2-27-2001-03, K2-27-2001-04, K2-27-2001-05, K2-27-2001-06, K2-27-2001-07, K2-27-2001-08, K2-27-2001-09, K2-27-2001-10, K2-27-2002-01, K2-27-2003-01, K2-27-2003-02, K2-27-2003-03, K2-27-2003-04, K2-27-2003-05, K2-27-2003-06, K2-27-2003-07, K2-27-2003-08, K2-27-2003-09, K2-27-2003-10, K2-27-2005-01, K2-27-2005-02, K2-27-2005-03, K2-27-2005-04, K2-27-2005-05, K2-27-2005-06, K2-27-2005-07, K2-27-2005-08, K2-27-2005-09, K2-27-2005-10, K2-27-2006-01, K2-27-2012-01, K2-27-2013-01, K2-27-2014-01, K2-27-2019-01, K2-27-2024-01, K2-27-2025-01, K2-27-2041-01, K2-27-2042-01, K2-27-2043-01, K2-27-2093-01, K2-27-2102-01, K2-27-2110-01, K2-27-2113-01, 2701-90134, 2701-90135, 2701-90136, 2701-90137, 2701-90138, 2701-90139, 2701-90140, 2701-90141, 2701-90142, 2701-90143, 2701-90144, 2701-90145, 2701-90146, 2701-90147, 2701-90148, 2701-90149, 2701-90150, 2701-90151, 2701-90152, 2701-90158, K2-27-2076-01, K2-27-2077-01, 2701-90154, 2701-90155, 2701-90156, 2701-90157)
- Registration date
- January 04, 2022
- Expiry date
- January 06, 2027
- Source update date
- August 21, 2023
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
Official value: II
Published parties
- Registrant / registration holder
- Stryker China Limited
- Manufacturer
- K2M, Inc.
Official description
Prosthesis Implantation Instruments, Orthopedic
Additional source fields
- AMD nomenclature code
- 13180
- Local responsible person phone
- 39691330
- Published manufacturer address
- 600 Hope Parkway SE, Leesburg, Virginia, 20175, USA
- Revision number
- d
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.