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AnyPlus PEEK Lumbar Cages

FDA UDI

Class II (US FDA UDI)

by GS Medical Co., Ltd.

Identity

Trade Name
AnyPlus PEEK Lumbar Cages FDA UDI
Generic Name
Polymeric spinal interbody fusion cage FDA UDI
Device Name
"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The implants are made of polyether-ether-ketone (PEEK OPTIMA LT1) (Manufacturer – INVIBIO) body (PEEK conforming to ASTM F2026) with the x-ray markers made of Tantulum (conforming to ASTM F560). The AnyPlus PEEK Lumbar Cage is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (""DDD"") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The AnyPlus PEEK Lumbar Cage is to be combined with internal supplemental fixation cleared for use in the lumbar spine." FDA UDI
Model / Reference
1103-3811 FDA UDI
Description
"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The implants are made of polyether-ether-ketone (PEEK OPTIMA LT1) (Manufacturer – INVIBIO) body (PEEK conforming to ASTM F2026) with the x-ray markers made of Tantulum (conforming to ASTM F560). The AnyPlus PEEK Lumbar Cage is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (""DDD"") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The AnyPlus PEEK Lumbar Cage is to be combined with internal supplemental fixation cleared for use in the lumbar spine." FDA UDI

Identifiers

Catalog Number
1103-3811 FDA UDI
Primary DI / UDI-DI
08806378362595 FDA UDI
510(k) Number
K100516 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Polymeric spinal interbody fusion cage FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Polymeric spinal interbody fusion cage

AnyPlus PEEK Lumbar Cages by GS Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymeric spinal interbody fusion cage.

Cleared under the same submission

K100516 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
GS Medical Co., Ltd.

Sources (1)

  • FDA UDI 654b6c38-21fa-41c4-ab78-8a1bd120cb6c 36 fields · synced Jun 1, 2026