Alphatec Solus Anterior Lumbar Interbody Fusion (ALIF) System Implants

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

SCIENT'X ASIA PACIFIC PTE. LTD.

Class:

Class C medical device

Manufactured by:

Alphatec Spine Inc.

Therapeutic area:

Orthopaedics

Therapeutic indications:

Intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2- S1 with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Solus implant is intended to be used with autograft.

Product summary:

Device System Info:[Sterile Medical Device], Sterilised by gamma irradiation with 3 years shelf life.; Models: SOLUS LUMBAR SPACER, 10mm MEDIUM, 7˚ LORDOTIC, STERILE - 25200-110-SEU, SOLUS LUMBAR SPACER, 12mm MEDIUM, 7˚ LORDOTIC, STERILE - 25200-112-SEU, SOLUS LUMBAR SPACER, 14mm MEDIUM, 7˚ LORDOTIC, STERILE - 25200-114SEU, SOLUS LUMBAR SPACER, 16mm MEDIUM, 7˚ LORDOTIC, STERILE - 25200-116-SEU, SOLUS LUMBAR SPACER, 12mm MEDIUM, 12˚ LORDOTIC, STERILE - 25200-312-SEU, SOLUS LUMBAR SPACER, 14mm MEDIUM, 12˚ LORDOTIC, STERILE - 25200-314-SEU, SOLUS LUMBAR SPACER, 16mm MEDIUM, 12˚ LORDOTIC, STERILE - 25200-316-SEU, SOLUS LUMBAR SPACER, 10mm LARGE, 7˚ LORDOTIC, STERILE - 25600-110-SEU, SOLUS LUMBAR SPACER, 12mm LARGE, 7˚ LORDOTIC, STERILE - 25600-112-SEU, SOLUS LUMBAR SPACER, 14mm LARGE, 7˚ LORDOTIC, STERILE - 25600-114-SEU, SOLUS LUMBAR SPACER, 16mm LARGE, 7˚ LORDOTIC, STERILE - 25600-116-SEU, SOLUS LUMBAR SPACER, 18mm LARGE, 7˚ LORDOTIC, STERILE - 25600-118-SEU, SOLUS LUMBAR SPACER, 12mm LARGE, 12˚ LORDOTIC, STERILE - 25600-312-SEU, SOLUS LUMBAR SPACER, 14mm LARGE, 12˚ LORDOTIC, STERILE - 25600-314-SEU, SOLUS LUMBAR SPACER, 16mm LARGE, 12˚ LORDOTIC, STERILE - 25600-316-SEU, SOLUS LUMBAR SPACER, 18mm LARGE, 12˚ LORDOTIC, STERILE - 25600-318-SEU

Authorization date:

2013-04-09