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Medical Device Division · registration 180537Active

Stryker Spine

Hong KongBone Graft SubstitutesClass IVStryker Spine, Inc.
Official record identity
MDACS listing number
180537
Model name
Vitoss Bone Graft Substitute (2102-0009, 2102-0010, 2102-0011, 2102-0015, 2102-0016, 2102-0020, 2102-0021), Vitoss Bone Graft Substitute Filled Canister (2102-0026, 2102-0027, 2102-0028, 2102-0029, 2102-0030, 2102-0031, 2102-0032, 2102-0033), Orthovita Synthetic Bone Graft Substitute - Cancellous Chips (2102-0131), Vitoss Foam Bone Graft Substitute (2102-1056, 2102-1100, 2102-1101, 2102-1105, 2102-1110, 2102-1120, 2102-1305, 2102-1310, 2102-1401, 2102-1402, 2102-1405, 2102-1410), Vitoss BA Bioactive Bone Graft Substitute (2102-1500, 2102-1505, 2102-1510, 2102-1520, 2102-1601, 2102-1602, 2102-1605, 2102-1610), Vitoss BA2X Bioactive Bone Graft Substitute (2102-2101, 2102-2102, 2102-2105, 2102-2110), Vitoss VBA Pack (2102-2401, 2102-2402, 2102-2405, 2102-2410), Vitoss BA BiModal Bioactive Bone Graft Substitute (2102-1901, 2102-1902, 2102-1905, 2102-1910), Vitoss BBTrauma Bioactive Bone Graft Substitute (2102-2201, 2102-2202, 2102-2205, 2102-2210), Vitoss BiModal Bioactive Bone Graft Substitute (2102-1800, 2102-1805, 2102-1810, 2102-1820)
Registration date
October 05, 2023
Expiry date
December 18, 2028
Source update date
March 06, 2024
Status
Active
Official value: Valid
Classification
Risk class
Class IV
Official value: IV
Published category
Bone Graft Substitutes
Published parties
Registrant / registration holder
Stryker China Limited
Official description

Bone Graft Substitutes

Additional source fields
AMD nomenclature code
37286
Local responsible person phone
39691330
Published manufacturer address
2 Pearl Court, ALLENDALE, NJ 07401 UNITED STATES
Revision number
a
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.