Chrysalis Intelligence · Sponsors · Premia Spine, Ltd.

Premia Spine, Ltd.

Ramat Poleg, Netanya, IL · 2 510(k) clearances · 11 PMAs · 1 recalls

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Total clearances

2

2023-07-07 → 2023-11-21

Last 12 months

0

Product codes

1

Most recent

2023-11-21

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	2	2023-11-21

Class III

PMA approvals (11)

Total PMA records

11

Originals + supplements

Distinct product codes

1

First decision

2023-06-15

Most recent

2026-05-29

Date	PMA #	Trade name	Type	Code	Device name	Specialty
2026-05-29	P220002-S009	TOPS System	Normal 180 Day Track	QWK	Prosthesis, Posterior Spinal Elements	Unknown
2025-10-29	P220002-S010	TOPS System	30-Day Notice	QWK	Prosthesis, Posterior Spinal Elements	Unknown
2025-05-29	P220002-S008	TOPS System	30-Day Notice	QWK	Prosthesis, Posterior Spinal Elements	Unknown
2025-03-25	P220002-S006	TOPS System	Normal 180 Day Track	QWK	Prosthesis, Posterior Spinal Elements	Unknown
2025-03-21	P220002-S007	TOPS System	30-Day Notice	QWK	Prosthesis, Posterior Spinal Elements	Unknown
2025-01-17	P220002-S005	TOPS System	30-Day Notice	QWK	Prosthesis, Posterior Spinal Elements	Unknown
2024-06-20	P220002-S004	TOPS System	Normal 180 Day Track	QWK	Prosthesis, Posterior Spinal Elements	Unknown
2023-10-27	P220002-S003	TOPS System	30-Day Notice	QWK	Prosthesis, Posterior Spinal Elements	Unknown
2023-09-07	P220002-S002	TOPS System	30-Day Notice	QWK	Prosthesis, Posterior Spinal Elements	Unknown
2023-08-11	P220002-S001	TOPS System	Normal 180 Day Track No User Fee	QWK	Prosthesis, Posterior Spinal Elements	Unknown
2023-06-15	P220002	TOPS System	Original	QWK	Prosthesis, Posterior Spinal Elements	Unknown

Safety

Recalls (1)

Class I (serious)

0

Risk of injury / death

Total recalls

1

Currently ongoing

1

Most recent

2025-07-16

Date	Severity	Status	Recall #	Product	Code	Reason
2025-07-16	Class II	Ongoing	Z-2516-2025	TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.	—	Potential for missing pins at tip of inserter.

Filings

All 510(k) clearances (2)

Date	K-number	Device	Code	Class	Specialty
2023-11-21	K232719	ProMIS Extension Rod System	NKB	Class II	Orthopedic
2023-07-07	K231844	ProMIS Fixation System	NKB	Class II	Orthopedic