FDA applicant

Custom Spine, Inc.

Parsippany, NJ14 decisions2005–20152 recalls

FDA records 14 decisions for Custom Spine, Inc. (Parsippany, NJ) from 2005 to 2015: 14 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and KWP (Appliance, Fixation, Spinal Interlaminal). Its devices cite 42 predicates, 10 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Custom Spine”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Custom Spine, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007high 3 (2009) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2016

2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Custom Spine, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Custom Spine, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Custom”

FDA records each applicant name separately; these may or may not be the same firm.

Custom Pack Reliability 21 Custom Medical Products, Ltd. 14 Custom Services Intl., Inc. 9 Custom Orthopaedic Solutions, Inc. 8 Custom Ultrasonics 6 Custom Surgical Products, Inc. 4 Custom Optical Frames, Inc. 4 Custom Medical, Inc. 3 Custom Medical Devices Intl., Inc. 3 Custom Cardio Components 2 Custom Medical Plastics, Inc. 2 Custom Hospitals Products 1

Custom Spine, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Custom”